Enforcement Report for January 25, 2012

1. Fresh Spinach sold under the following brand names: 1) Better Brand Fresh Spinach, 10 oz; 2) Krisp Pak Brand Fresh Spinach, 10 oz. Grown in USA. Recall # F-0602-2012;
2. Avon Heights - Select Savoy, 2.5 lb. Grown in USA. Recall # F-0603-2012

1. Fromagerie Marie Kade Akawi Cheese Establishment number 1874 300-400 g; UPC 7 78546 07000 8. Recall # F-0606-2012;
2. Fromagerie Marie Kade Baladi Cheese Establishment number 1874 300-400 g; UPC 7 78546 02000 3. Recall # F-0607-2012;
3. Fromagerie Marie Kade Shinglish Cheese Establishment number 1874 approx. 200 g; UPC 7 78546 10000 2. Recall # F-0608-2012;
4. Fromagerie Marie Kade Tresse Cheese Establishment number 1874 300-400 g. UPC 7 78546 01000 4. Recall # F-0609-2012;
5. Fromagerie Marie Kade Vachekaval Cheese Establishment number 1874 300-400 g; UPC 7 78546 11000 1. Recall # F-0610-2012;
6. Fromagerie Marie Kade Halloom Cheese Establishment number 1874 300-400 g;
   UPC 7 78546 03000 2. Recall # F-0611-2012;
7. Fromagerie Marie Kade Moujadale Cheese Establishment number 1874 300-400 g Packaged in flexible plastic; UPC 7 78546 04000 1. Recall # F-0612-2012

1. Best before and up to 08 MAR 2012;
2. Best Before and up to 08 FEB 2012;
3. Best Before and up to 07 NOV 2012;
4. Best Before and up to 10 NOV 2012;
5. Best Before and up to 10 MAR 2012;
6. Best Before and up to 01 May 2012;
7. Best Before and up to 04 May 2012

1. Fruta Cristalizada (Cubos) Net Wt: 8.8 Oz. (250 gr.) Product of Portugal Packaged in non-flexible plastic container, UPC Code: 5601528837137. Recall # F-0599-2012;
2. Confeitaria da Ajuda Chrystallized Assorted Fruit Cubes, Net Weight: 350 oz (5 kg.). Packaged in a cardboard box. Recall # F-0600-2012

1. None;
2. Lot # SS0009, Best before March 2012 end:

1. Breaded Herring Fillets (Opiekane filety sledziowe panierowane); packed in glass jars, Net wt. 14 oz. (400 g) drained 7 oz. (200 g); Product of Poland; UPC 6 17115 00501 3. Recall # F-0604-2012;
2. Breaded Mackerel Fillets (Opiekane filety z makreli panierowane); packed in glass jars, Net wt. 1 lb. 7 oz. (650 g) drained 12 oz. (350 g); Product of Poland; UPC 6 17115 00502 0. Recall # F-0605-2012

1. Best Before 02/24/12 343H, 03/20/12 373H, 03/30/12 394H and 03/30/12 395J;
2. Best Before 03/13/12 352G, 03/20/12 372G, 03/20/12 373H and 03/30/12 394F

1. 1mL Vials (NDC 0703-6801-01);
2. box of 25 single dose vials (NDC 0703-6801-04) and
3. 1mL Prefilled Syringes (NDC 0703-6811-21), Rx only, For IM Use Only. Recall # D-1180-2012

1. Lot numbers 31310301B, exp 12/2011; 31310788B, exp 1/2012; 31311008B, exp 4/2012;
2. lot numbers - 31310787B, exp 1/2012; 31311357B, exp 4/2012; and
3. lot numbers 31311217B, exp 2/2012; 31311219B, exp 2/2012; 31312156B, exp 4/2012; 31312300B, 4/2012.

1. Cryoprecipitated AHF, Pooled. Recall # B-0378-12;
2. Plasma Frozen within 24 hours (FP24). Recall # B-0379-12;
3. Red Blood Cells Leukocytes Reduced. Recall # B-0380-12

1. Unit: 6571965;
2. Units: 6568228; 6548844;
3. Units: 6568228; 6571965; 6548844

1. Recovered Plasma. Recall # B-0427-12;
2. Red Blood Cells Leukocytes Reduced. Recall # B-0428-12;
3. Cryoprecipitated AHF. Recall # B-0429-12;
4. Fresh Frozen Plasma. Recall # B-0430-12;
5. Plasma Frozen Cryoprecipitated Reduced. Recall # B-0431-12

1. Units: 1811150, 1808269, 1711496, 1708784;
2. Units: 1811150, 1808269, 1711496, 1710737, 1708784, 1617461;
3. Unit: 1617461;
4. Unit: 1710737;
5. Unit: 1617461

1. Recovered Plasma. Recall # B-0447-12;
2. Plasma Frozen. Recall # B-0449-12

1. Unit: 20FK26699;
2. Unit: 20FK26976

1. LifeStar ACT I Sensor Ambulatory Cardiac Telemetry; an automatically activated system with a single channel EKG, office hookup and auto send/auto detect that requires no patient intervention to either capture or transmit an arrhythmia when it occurs; Model FG-00065 LifeStar ACT provides critical ECG information by capturing the onset and termination/escape of an arrhythmia to assist in correctly identifying and treating the patient. Patients are monitored for up to 30 days and all of the data is available at the request of the physician during the service period and for 7 days following the end of service. Recall # Z-0206-2012;
2. LifeStar ACT III Platinum Sensor Ambulatory Cardiac Telemetry; an automatically activated system with a high performance triple channel EKG, office hookup and auto send/auto detect that requires no patient intervention to either capture or transmit an arrhythmia when it occurs; Model FG-00084 LifeStar ACT provides critical ECG information by capturing the onset and termination/escape of an arrhythmia to assist in correctly identifying and treating the patient. Patients are monitored for up to 30 days and all of the data is available at the request of the physician during the service period and for 7 days following the end of service. The ACT III will provide more sensitive data for initial or early detection of arrhythmia in patients that have minimal or atypical symptoms. Recall # Z-0207-2012;
3. ACT Cellular Phone Monitor; a component of the ACT Ambulatory Cardiac Telemetry; an automatically activated system with a high performance EKG, office hookup and auto send/auto detect that requires no patient intervention to either capture or transmit an arrhythmia when it occurs; there are two models used with either the ACT 1 sensor or the ACT III sensor: a) Model Ozone-HTC b) Model BlackJack2 SGH-i617 LifeStar ACT provides critical ECG information by capturing the onset and termination/escape of an arrhythmia to assist in correctly identifying and treating the patient. Patients are monitored for up to 30 days and all of the data is available at the request of the physician during the service period and for 7 days following the end of service. Recall # Z-0208-2012

1. All serial numbers with firmware REV 01.G;
2. All serial numbers with firmware REV 10.4;
3. All serial numbers with software version 5.5.9

1. Maquet Servo-i ventilator system Device Part number 64 87 800, 510 k 041223 Device Listing No. B052264. Intended for treatment of and monitoring of patients in range of neonates, infants and adults with respiratory failure of respiratory insufficiency; used only by healthcare providers in hospitals or healthcare facilities and for in hospital transport. Recall # Z-0352-2012;
2. Maquet Servo-S ventilator system Device Part number 66 40 440, 510 k 041223; Device Listing No. B052264. Intended for treatment of and monitoring of patients in range of neonates, infants and adults with respiratory failure of respiratory insufficiency; used only by healthcare providers in hospitals or healthcare facilities and for in hospital transport. Recall #Z-0353-2012;
3. Maquet PC Board PC1772 Spare Part Device Part number 64 67 620, 510 k 041223 Device Listing No. B052264. Intended for treatment of and monitoring of patients in range of neonates, infants and adults with respiratory failure of respiratory insufficiency; used only by healthcare providers in hospitals or healthcare facilities and for in hospital transport. Recall # Z-0354-2012

1. Lot number S/N 48396-49564;
2. Lot number S/N 16783-17318;
3. No lot S/N

1. ActiveCare +SFT Medical Compression Systems. Intended for use in: Preventing deep Vein Thrombosis; Enhancing blood circulation; Diminishing post-operative pain and swelling; Reducing wound healing time; treatment and assistance in healing of stasis dermatitis, venous stasis ulcers and diabetic leg ulcers; Treatment of chronic venous insufficiency and; Reducing edema. Device Catalog Number A502B-0001-01 and A502B-0002-01. Recall # Z-0386-2012;
2. ActiveCare DVT Medical Compression Systems. Intended for use in: Preventing deep Vein Thrombosis; Enhancing blood circulation; Diminishing post-operative pain and swelling; Reducing wound healing time; treatment and assistance in healing of stasis dermatitis, venous stasis ulcers and diabetic leg ulcers; Treatment of chronic venous insufficiency and; Reducing edema. Device Catalog Number A502B-0001-02 and H502B-0001-07. Recall # Z-0387-2012

1. Syringe Lot No. 183058; Package Lot No. 186272, 186665, 186676;
2. Syringe Lot No. 183058; Package Lot 182990, 186133, 188996

1. Baxter Interlink System Continu-Flo Solution Set, 71" (1.8 m), 2 Injection Sites, Male Luer Lock Adapter, Standard Bore 3-Way Stopcock Manifold, Extension Set, 44" (112 cm), Vol. 6.6 mL, Injection Site, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the patient; product code 1C8369. Intended use: for the administration of drug and solutions to patient's vascular system through a vascular access device. Recall # Z-0469-2012;
2. Baxter Interlink System Continu-Flo Solution Set, 69" (1.8 m), 2 Injection Sites, Male Luer Lock Adapter, Standard Bore 4-Way Stopcock with Rotating Male Luer Lock,, Extension Set, 61" (155 cm), Vol. 8.5 mL, 2 Injection Sites, Male Luer Lock Adapter with Retractable Collar; an Rx sterile, nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the patient; product code 1C8371 Intended use: for the administration of drug and solutions to patient's vascular system through a vascular access device. Recall # Z-0470-2012;
3. Baxter Interlink System Extension Set, 20" (51 cm), Vol. 2.9 mL, Injection Site, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the patient; product code 1C8376 Intended use: for the administration of sterile I.V. fluids to the patient. Recall # Z-0471-2012;
4. Baxter Interlink System Vented Continu-Flo Solution Set, 100" (2.5 m), Vol. 2.9 mL, 3 Injection Sites, Male Luer Lock Adapter with Retractable Collar; an Rx sterile, nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the patient; product code 1C8533 Intended use: for the administration of sterile I.V. fluids to the patient. Recall # Z-0472-2012;
5. Baxter Interlink System Y-Type Solution Set, 78" (2.0 m), 2 Injection Sites, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the patient; product code 1C8581 Intended use: for the administration of drug and solutions to patient's vascular system through a vascular access device. Recall # Z-0473-2012;
6. Baxter Interlink System Continu-Flo Solution Set with Control-A-Flo Regulator, 89" (2.3 m), 2 Injection Sites, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the patient; product code 1C8621 Intended use: for the administration of drug and solutions to patient's vascular system through a vascular access device. Recall # Z-0474-2012;
7. Baxter Interlink System Extension Set, 13" (32 cm), Check Valve, Injection Site, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the patient; product code 2C6605 Intended use: for the administration of drug and solutions to patient's vascular system through a vascular access device. Recall # Z-0475-2012;
8. Baxter Interlink System 3-Port Manifold with Check Valves, Vol. 1.0 mL, Large Bore 4-Way Stopcock Extension Set, Vol. 6.2 mL, 41" (104 cm), 2 Injection Sites, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the patient; product code 2C6921 Intended use: for the administration of sterile I.V. fluids to the patient. Recall # Z-0476-2012;
9. Baxter Interlink System Continu-Flo Solution Set, length 89" (2.3 m), 2 Injection Sites, Male Luer Lock Adapter, 3-Port Manifold with Check Valves, Vol. 1.0 mL, Large Bore 4-Way Stopcock Extension Set, Vol. 6.2 mL, Length 41" (104 cm), 2 Injection Sites, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the patient; product code 2C6931 Intended use: for the administration of sterile I.V. fluids to the patient. Recall # Z-0477-2012;
10. Baxter Interlink System Continu-Flo Solution Set, length 89" (2.3 m), 2 Injection Sites, Male Luer Lock Adapter, 3-Port Manifold with Check Valves, Vol. 1.0 mL, Extension Set, Vol. 5.6 mL, Length 39" (99 cm), 2 Injection Sites, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the patient; product code 2C6951 Intended use: for the administration of sterile I.V. fluids to the patient. Recall Z-0478-2012;
11. Baxter Interlink System Solution Set, 67" (1.7 m), Injection Site, Male Luer Lock Adapter, Standard Bore 4-Way Stopcock Manifold, Extension Set, 43" (109 cm), Vol. 6.5 mL, Injection Site, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the patient; product code 3C0039 Intended use: for the administration of drug and solutions to patient's vascular system through a vascular access device. Recall #Z-0479-2012;
12. Baxter Interlink System Continu-Flo Solution Set, 71" (1.8 m), 2 Injection Sites, Male Luer Lock Adapter, Standard Bore 4-Way Stopcock Manifold, Standard Bore 4-Way Stopcock with Rotating Male Luer Lock, Extension Set, 39" (99 cm), Vol. 5.8 mL, Injection Site, Male Luer Lock Adapter, Extension Set, 8" (20 cm), Vol. 1.1 mL, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the patient; product code 3C0142 Intended use: for the administration of sterile I.V. fluids to the patient. Recall Z-0480-2012;
13. Baxter Interlink System Straight Type Blood Set with 40 and 150 Micron Dual Screen Filter, Length 86" (2.2 m), Injection Site, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the removal of micro aggregates from whole blood or red blood cells and transfusion of platelets; product code 4C6832 Intended use: for the removal of micro aggregates from whole blood or red blood cells and transfusion of platelets. Recall # Z-0481-2012;
14. Baxter Interlink System Y-Type Blood/Solution Set with 40 and 150 Micron Dual Screen Filter, Length 95" (2.4 m), Injection Site, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the removal of micro aggregates from whole blood or red blood cells and transfusion of platelets; product code 4C6838 Intended use: for the removal of micro aggregates from whole blood or red blood cells and transfusion of platelets. Recall # Z-0482-2012

1. Lot number GR296251;
2. Lot number GR295493;
3. Lot number GR294363;
4. Lot number GR295337;
5. Lot number GR296137;
6. Lot numbers GR295352, GR296095 and GR296335;
7. Lot number GR295725;
8. Lot number GR295634;
9. Lot numbers GR295956, GR296095, GR296848 and GR297416;
10. Lot number GR296053;
11. Lot number GR295642;
12. Lot numbers: GR295287 and GR29641;
13. Lot number: GR296319;
14. Lot number: GR29538

1. GE Healthcare Definium 8000, Digital Radiographic Systems. Revolution XR/d Digital Radiographic Imaging System with Image Pasting and Auto positioning is indicated for use in generating radiographic images of human anatomy. This device is not intended for mammographic applications. Recall # Z-0584-2012;
2. GE Healthcare Discovery XR650, Digital Radiographic Systems. System ID SLQDSC1. Revolution XR/d Digital Radiographic Imaging System with Image Pasting and Auto positioning is indicated for use in generating radiographic images of human anatomy. This device is not intended for mammographic applications. Recall # Z-0585-2012

1. 205801KDEF1 734671DEF1 205801KDEF2 336716BCR4 907580RM5 305325SM1 252847DEF6 313745ORTHO1 540536DRAD2 OCPINED8K 614566DR1 808951XRDB 315376D8K 843789VR2 419621DR 313745ORTHO2 734998ORTHO1 361572MOBD8K 478MORTHOD8K 720494D8K 559SKDHD8K 734647DEF1 SLQDEF1 212533DEF 484565DEF2 808951XRDA SCOIVALD8000 210617H122 208422D8000 512268D8000 954265ME4 216844XRD1 706721MDR2 717763MPXRD1 SLPDEF1 NYPHC370913 603225DRAD 225358DEF1 708364D8K 708202D8K2 NYPHC370910 847688DX2 928757DR3 252ECHI8K 970DOA8K 856355DEF NYPHC370911 850416DXR NYPHC370914 NYPHC370912 503387D8K 419424DR 704323M8K 315338D8K 215823DEF1 828696RM1 617739RM1D1 MCCD8K 915564DRAD 573632CROR1 304256DEF 501868ACHBR 801285DR1 937296D8K 865429DR1 908522DIF 610526DEF1 330477XRD 813844USFR1 205949DEF1 360417SQRAD1 412688RM2 330543DR1 815525DEF8K 908668DIF 216844MSIXRD2 732294DIF 650474SNCTHU5 360417SQRAD1 216844MSIXRD 617754XRD2A 210208ER 573875CRM4 712264DF8000 314577CGRM3 313745PDDEF OAASPINE 706494HC1 503216XRD1 303340DXR 814234RAD5 717761XRD1 313745ERDEF 920885DXRD 617414ACC2 239593OTS 440974XRD3 210593RAD1 573875CRM4 210396XRD1 949219RAD OAAIMAGE 706494HC2 210804RAD1 641422RM5 617667ORTHO1 412749DEF8000 814234RAD7 617667DR6 617414ACC4 217383CDEF1 617724XR2A2 504868DF 706494HC4 210489RAD1 904WSRAD1 610954DEF 904WSER1 614293D8K 601984XRD1 330455XRD 608392DEF1 715839D8000 847437GEXRD1 973971RAD2 717544HCXRD1 717544HCXRD2 432522WCDR1 228809SRER 570621DEF 319272XRD8 903GSER NYPAL240 617726XR1CP4 269789DEFINIUM 608785DEF 920965DEF 305662ER 952746XRD2 716250CH1 610378RM1 630978DEF 757466RM6 ACB21739DEF 903UTD8 850431ER1D 541677MOIDR2 724775DEF 570621DEF2 503216XRD1 412858DEF1 408363VATHU1 719553SCCD8 816234CDR4 765832WC2 901765DR 406782BODR1 305662RM3 864512EDRM2 636947DEFRM2 920965EDEF 410337ER1 801587DX2 NYP404030 801587DX3 304757DEF8000 281274THUNDER 318681SRM1 239432D8000 601968XRD1 801587DX1 228377ER 904996RAD 773STJXRD321 979282THUNDER 513247D8K 816501RAD2 863284XRD 806212DRAD 412647DEF 432685DDR1 202741XRD 718630XRD 206598UDEF245 206598UDEF204 817329D8000 816501RAD3 720225CRXRDX 240566DR1 719333DEFC 305662RM3 610886DX1 913588KUW8K 734671DWS ACB71029DEF NYPMIL3-113 360689DX 210704PDIG1 504896D8K 956323RM3 281477MWXD2 717299XRD1 860659D8000 913696CDR1 419383ORTHO3 225754DEF1 734998BWDEF 419383ORTHO1 610954DEF2 706721MDR1 330486XRD 757722C212 734936DEF1 503513XRD NYPVC113 830331DIG1 478633DF8 207283DEFRAD1 607274DRAD1 334826HCA 661SCOID8000 978774DX1 313343DEF1 973538RAD 863680RM6 2682721 517353DEF1 206598RAD1 419783DR 650696XRD2 614257D8K 614293DR 216778XRD1 920721DEF 617724XR1A2 325670DEF1 206598UDEF247 508941RM11 727767XRAY1 978466DEF1 915747ERRAD 586532D8000 314849SLO1 704783DEF2 781344XRD2 714966RM5 925939ER1 415600CALDEF 704323DEF1 COR381050 850883ER1 541743DR5 M54219 314523OD8K 412647EDR1 949759D8 505265XRM6 813879XRD 602277A2228 505265XRM4 801662DX 906225D8K 207553DEF 229DEF8000 804SMHER2 207779DEF 704783DEF5 904202ORAD 404251DEF1 650474SNCTHU2 417781SJER 281482DR1 732923DIF1 404712DEF1 719SGPDR1 760873RAD 330363R1 212241RAD1 541768RM1 334528EAORTHO 419455DR 406457HODR1 920406DEF 330558D8 734936DEF2 650497SHTHU1 216791XRD1 617889XR1CH 734930MSDEF 541267DR1 623327D8000 412784VADEF 650474SNCTHU4 573814VARAD1 407VADEF1 303399XRD8K HIP816DEF1 415UCDEFORTHO 619532DEF15 650474SNCTHU1 251415RAD 724836DEF1 321841DEF1 503732XRD 913588KD8K 281274MSD8000 904399CHEST 859313DEFB 732776D8K 812343DEF1 614293SRDR 706733VAUD2 609219D8K 704323DEF2 409839D8000 920725DEF 301295DEF8 925939ER2 SPINEDEF1 706322SFSC 517353DEF2 210638RAD3 412692ORTHO2 706787ORTHO 650474SNCTHU6 650474SNCTHU3 717544HPXRD1 JAC2W11 303651DEF2 757388RP3 706733VR6 217326CCH2 509837SDEF 337234LBJ1 503VAHD8K 412692R1 206764DEF 713441ORTHORAD 808433D8KRM4 425455PROORTHO 734998ORTHO2 404321DEF1 720225LMCD8K 239768RM1 386FHOR1 508422DEF4 210617H104 724772DEF1 218722DEF 425392PRO1 360414XRD1 985882RAD1 978XR1NS 813827DEF8K 303321XRD8K 816234COPC 360417RAD1 00100RAD05 00123RAD05 00440RAD16 00454RAD02 00356RAD07 00226RAD08 01059RAD02 00065RAD08 10563RAD03 00065RAD07 00824RAD02 00065RAD06 00521RAD05 10086RAD03 00116RAD04 00324RAD09 AE1010RX04 61007RAD02 61012RAD01 06014RAD02 856070190 426020XR03 K001RX02 M001RX32 M001RX34 O010RX07 K002RX03 CEE15654 DE641219 DEG27409 DE644605 DPN88401 MPX27410 DEN51301 FPG86423 DEN00500 DEN00300 DEN00400 FPG93006 YE626921 DEN00200 DEN00100 DPM32148 DEN00301 DEL89966 DEN00704 DE541A09 DEN00000 DEN01005 DEN00805 DEN00602 DEN01105 EP591318 FEG85904 DEN00611 DEN90700 DPM32147 DPN26321 CEL75708 CEZ08802 CE165327 CEZ04110 CE262911 DEN01708 DE203238 DPL32925 ME504381 UE535A106 NE203136 DPB15839 GEX00400 ZA1000RX05 SA2177RX01 RU1785RX02 RU1646RX03 850070809 850070813 850070760 850070763 850070767 850070773 850070766 850070778 850070751 PER64201 PER18111 PER18410 NO1015RX08 NO1108RX03 NO1052RX08 NO1016RX07 NO1077RX03 920079103 920079105 920079110 RTD0986 MQ1000RX09 JO1000RX02 WX0102 WX0210 WX0211 XK0102 WX0203 WX0202 WX0201 WX0204 WX0205 WX0206 A5102680 A5356251 A5300722 B5300707 A5115127 A5624113 B5120721 A5804416 A5814918 A5238814 A5317201 A5317202 A5164518 A5128409 C5237807 B5127421 IL1062XR11 IE1044RX01 IE1044RX02 IE1111RX01 828070118 828070120 828070121 828070125 828070124 828070109 828070113 828070117 H2009RAD35 UHAN01XR13 HC0881XR04 HROS01XR03 487692XR02 PC0362XR07 HC7048XR05 519926XR03 561559XR02 HC0399XR08 PC6132XR07 PF1000RX11 M4168064 X59007318 A4192906 P4211488 M4187723 M4202413 M1966307 B4191737 M4472226 M4195131 M4211061 M4215549 A1717401 M9164773 M2717507 M177858601 A4167326 X1135601 M4484739 M4135317 M4173815 B4195724 M4168125 M4171226 M4185525 M4467029 A190136602 M5484954 A2035104 FI1052RX02 FI1144RX01 FI1017RX01 FI1133RX01 DK1043RX03 CS1004RX05 CS1090RX02 CS1013RX07 CS1013RX06 CS1138RX01 CS1013RX08 82407210082 82407250068 82407130221 82407040419 82407070112 82407160269 82407070114 82407040429 082407120178T 82407160279 82407040366 82407040371 82407040372 82407040373 82407040374 82407040384 82407160242 82407040398 82407040393 82407160244 82407070117 82407120178 27305DEF 27305DEF2 416813DEF8000A 905883DEF3 905883DEF1 905883DEF2 902473DEF1 514338DEF2 514338DEF3 519646DEF1 709778ADEF1 709778DEF1 519534XRD2D 416756D8000 416284DEF 519376XRD1 506452RM2A 519986RAD 519376XRD2 905522DEF 519797DEF 416284DEF2 519538RAD2 204787DEF 204787DEF2 416469DEF2 514473DEF 709637DEFINIUM 506375DEF1 416469DEF2 604557RAD4 403639RAD1 604557RAD1 604557RAD3 905848DEF1 403349ARAD2 416323DEF 905848DEF2 905895DEF 506857DEF1 418276DEF8000 514431DEF 709737RAD5 709737RAD4 030240RX04 030419RX08 190059RX20 220078RX30 080041RX14 AH3403XR03 AH6834XR02 AP4502XR08 AP3408XR10 910072181 910074017 910072141 910092229 910073084 910073085 910072169 910074018 910074022 910074021 1821DEF80 3882754403XRMET;
2. 414649DIS650 603668C6 704323M650 843789VR1 202865XRD650 727581DC650 508693MVDR 423624DIS6 412367MPI 832505DR1 713873BONE1 734462LIVXR1 423624DEF8 614722D650 OCMATT650 704323U650 650497CHDIS1 908685D650 540498RM2 203694ER650A 605226XR650 651439XR650 573884XR2 573884XR1 573884XR3 281477MW650XR1 281477MW650XR2 713441MM650 605719XR650 716631DRAD1 309655FXR3 3026291 320202XR650 303PSL650 573884XR4 412367D650 415CPSUTDEF2 650MPXR6502 734998BW650 VALLCXR650 615349RM2 417625OPD 832505DR3 814375RM1 832505DR2 315787RAD1 443481SJK1 616267XR650A 913696CDR2 623251DR1063 650MPPAMOB 860749XR650 386FHDVR1 281MWXR6501 812482DR1 818364ER 617SHLL515 617SH4333 205933DXR 307773D650 413748RAD6 614722D650R2 504842RM2 802773D650 520DMXR650 915742DRAD1 301295XR650 210358DIG1 313576XR650 415221VA650 SLH650 810494D650A LLPMXR650R2 NYPAL172 814788D650 706733VR4 516608D650 ORMCXR380 816234CDR5 SLHWG650 ORMCXR386 443481ED2 409761PCP2 970395XR650 571231DX2 810494D650B 508334DRAD 573875XR3 650MPPAMF2 210358UCCHRM1 310319DISCXR5 310319DISCXR4 412623ER1 816234COPC1 310319DISCXR3 310319DISCXR2 585596DRAD 409761PCP1 301765RAD 719285XR650 406495SPDR1 816960CDR1 309655GPR1 415UCMBD6501 415UCMBD6502 0002852904BX 573815BR2D 920830RAD2 708202D650 713441MO650 908522D650 281STLV6501C143 504842RM1 601936ERXRD ORMCER2 ORMCER1 504349R9 571231DX1 609247RAD1 SLRBONE 00216RAD14 00001RAD11 00440RAD23 00424RAD06 AE1016RX10 AE1016RX09 856070221 S001RX08 M001RX40 M001RX39 ME051547 SA1011RX10 SA1056RX02 SA1012RX19 SA2191RX03 SA1008RX01 SA2235RX01 SA2249RX01 SA2191RX05 SA2244RX01 SA1056RX03 SA2253RX01 SA1056RX04 SA1011RX11 SA2240RX01 850070828 850070841 850070840 NO1051RX02 WV0301 WV0151 WV0201 WV0160 WV0251 WV0206 WV0210 WV0154 WV0303 WV0302 WV0304 WV0153 WV0208 WV0254 WV0209 WV0253 WV0152 A5604844 A51272107 A51026100 A51026102 828070123 PHAM02XR04 PP0034XR02 HC9059XR03 HC2636XR02 558739XR03 A4194835 M4173034 M4206219 M4008407 M2348213 M4461517 M23084302 M23084301 M1656626 B6010815 M4200018 M4196643 FI1128RX02 EE1016RX01 82407110065 82407040425 82407040432 82407100420 82407220044 82407040436 82407040447 82407100410 82407040431 82407110068 82416300005 82407300033 82407090149 506357RAD1 604869XR 905527DEF4 905527DEF2 613548RAD1 905527DEF1 604582XR2 604582XR1 250339XR1 250370XR1 514765XR650 250746XR1 905521XR650A 514934BRAD3 418689XRD 418547XR1 BA4080RX02 BA4017XR04 030220RX14 910073103 910072201 910074030 910075020 910072215

1. DURAMAX 15.5 F x 22 cm Chronic Hemodialysis Catheter Set (With Cuff 17 cm from Tip), DuraMax Stacked Tip 22 cm Str. Basic Kit, Catalog No./REF 10302802, STERILE. The AngioDynamics DuraMax Chronic Hemodialysis Catheter is indicated for use in attaining long-term vascular access for Hemodialysis and apheresis. Recall # Z-0586-2012;
2. DURAMAX 15.5 F x 24 cm Chronic Hemodialysis Catheter Set (With Cuff 19 cm from Tip), DuraMax Stacked Tip 24 cm Str. Basic Kit, Catalog No./REF 10302803, STERILE --- The AngioDynamics DuraMax Chronic Hemodialysis Catheter is indicated for use in attaining long-term vascular access for Hemodialysis and apheresis. Recall # Z-0587-2012;
3. DURAMAX 15.5 F x 28 cm Chronic Hemodialysis Catheter Set (With Cuff 23 cm from Tip), DuraMax Stacked Tip 28 cm Str. Basic Kit, Catalog No./REF 10302804, STERILE --- The AngioDynamics DuraMax Chronic Hemodialysis Catheter is indicated for use in attaining long-term vascular access for Hemodialysis and apheresis. Recall # Z-0588-2012;
4. DURAMAX 15.5 F x 32 cm Chronic Hemodialysis Catheter Set (With Cuff 27 cm from Tip), DuraMax Stacked Tip 32 cm Str. Basic Kit, Catalog No./REF 10302805, STERILE --- The AngioDynamics DuraMax Chronic Hemodialysis Catheter is indicated for use in attaining long-term vascular access for Hemodialysis and apheresis. Recall # Z-0589-2012;
5. DURAMAX 15.5 F x 36 cm Chronic Hemodialysis Catheter Set (With Cuff 31 cm from Tip), DuraMax Stacked Tip 36 cm Str. Basic Kit, Catalog No./REF 10302806, STERILE --- The AngioDynamics DuraMax Chronic Hemodialysis Catheter is indicated for use in attaining long-term vascular access for Hemodialysis and apheresis. Recall # Z-0590-2012

1. Lot C28712;
2. Lots 500137, 500138, 527756, C28713;
3. Lots 500139, 527573, 527755, C28714;
4. Lots 527842, C28715;
5. Lots 523908, 527961, C28716

1. Orbit and Orbit Micro Subcutaneous infusion set Triad alcohol wipes are co-packaged with the Orbit devices. Our device is within its own separate sterile package and the wipes are packaged with our devices within an outer container. Removal of the wipes will not compromise the sterile barrier of our device and can easily be identified and replaced. Recall # Z-0592-2012;
2. IV Start Kits Convenience kit for starting IVs. Triad wipes are packaged within the sterile barrier and would require compromising the barrier to replace the wipe. Recall # Z-0593-2012

1. Catalog # Lot # B7905: 2010928, 2010955, 2010956, 2026848, 2026849, 2026852; B7932: 2010961, 2012567, 2012965, 2022800; M1861: 1724481 M2461: 1701070; M2491: 1706450; M3060: 1711976; M3091: 1701069; M4261: 1711981; P1005: 1992939; P1850: 1887213; P1851: 1646310, 1646311, 1750036, 1863485, 1887212, 1972548, 2013176; P1861: 1385494, 1711980, 1752814; P1881: 2027824; P1891: 1471913; P2450: 1800862; P2451: 1598200, 1598201, 1598206, 1750038, 1800860, 1815008, 1851423, 1887209, 1887216, 1972553; P2460: 1470415, 1722014; P2461: 1087509, 1385394, 1598097, 1774378, 1803640, 1848045, 1971554, 2022098; P2481: 1999027, 1999484, 2022794, 2027826; P2491: 1363050, 1557296, 1692396, 1782845; P3051: 1366012, 1646308, 1646312, 1660580, 1660581, 1800858, 1841693, 1853574, 1887208, 1887215, 1887217, 1972556, 2027827; P3061: 1062302, 1087495, 1686643; P3081: 1919294, 1972551, 1978024, 2027828; P3091: 1244139, 1244140, 1244141, 1363051, 1598101, 1598102, 1686641, 1686644; P4251: 1646309, 1646313, 1871643, 2022795; P4260: 1439395; P4261: 1363053, 1722015; P4281: 2027825, 2045107; P4290: 1439397; P4291: 1363049, 1722019, 1761743, 1774372, 1774374, 1774375, 1774376, 1774377, 1774379, 1774380, 1782841, 1782842, 1782843, 1782844, 1799794, 1799795, 1799796, 1799797, 1799798, 1814994, 1848046, 1855183, 1972546, 2007344, 2027816. P4291M: 1863467, 186468, 1863469, 18687998, 1887999, 1888000, 1888001, 1888002, 1888003, 1888004, 1888005, 1888006, 1972538, 1972539, 1972542, 1975233, 1990393, 1990395, 1991948, 2006952, 2006953, 2006954, 2006955, 2007432, 2022118, 2026307, 2026308, 2026309, 2027903, 2027904, 2028415;
2. Catalog # : Lot # B7825: 253026-SC, 253046-SC, 253069-SC, 253073-SC, 253081-SC, 253103, 253112, 253120, 253125, 253130, 253144, 253183, 253199, 253216, 253226, 253234, 253245, 253258, 253269, 253281, 253294, 253300, 253301, 253313, 253326, 253341, 253348, 253363; B7837: 233068-SC, 253037-SC, 253041-SC, 253049-SC, 253053-SC, 253057-SC, 253060-SC, 253064-SC, 253074-SC, 253080-SC, 253084-SC, 253087, 253088, 253097, 253100, 253104, 253109, 253113, 253121, 253126, 253133, 253136, 253140, 253146, 253149, 253152, 253159, 253168, 253171, 253177, 253181, 253187, 253188, 253190, 253194, 253196 253198, 253200, 253205, 253207, 253208, 253210, 253214, 253219, 253223, 253227, 253231, 253235, 253238, 253243, 253246, 253251, 253254, 253255, 253257, 253262, 253264, 253272, 253273, 253275, 253278, 253280, 253283, 253288, 253292, 253295, 253299, 253307, 253311, 253315, 253318, 253319, 253324-SC, 253328, 253331, 253336, 253338, 253342, 253350, 253351, 253356, 253358, 253366, 253370, 253372, 253374, 253381, 253384-SC, 253388, 253390, 253392, 253396, 253399, 253401, 253406, 253409, 253411, 253413, 253417, 253421, 253422, 253426, 253432, 253435, 253437, 253439, 253444, 253451, 253452, 253457, 253466, 253470, 253473, 253475, 253476, 253479, 253485, 253491, 253495, 253496, 253500, 253502, 253505, 253512, 253519, 857-SC4; B7841: 233163, 253028-SC, 253033-SC, 253052-SC, 253056-SC, 253065-SC, 253070-SC, 253078-SC, 253091, 253099, 253101, 253106, 253115, 253119, 253124, 253128, 253141, 253147, 253153, 253156, 253169, 253172, 253180, 253191, 253204, 253211, 253222, 253228, 253236, 253242, 253247, 253253, 253261, 253271, 253274, 253279, 253282, 253289, 253297, 253302, 253304, 253308, 253316, 253322, 253327, 253329, 253333, 253339, 253343, 253346, 253352, 253357, 253367, 253369, 253375 800 253379 , 253383-SC, 253391, 253397, 253402, 253410, 253414, 253418, 253420, 253425, 253430, 253438, 253440, 253453, 253455, 253458, 253468, 253469, 253477, 253480, 253486, 253492, 253504, 253506, 253511, 253515, 253521, 253530; B7842: 20600, 253036-SC, 253040-SC, 253062-SC, 253079-SC, 253107, 253116, 253142, 253157, 253166, 253175, 253192, 253195, 253212, 253224, 253240, 253249, 253276, 253286, 253305, 253320, 253332, 253344, 253364, 253376, 253380, 253385, 253407, 253415, 253423, 253436, 253441, 253459, 253462, 253481, 253487, 253493, 253503, 253535; B7844: 253047-SC; B7846: 253513; B7905: 2010928, 2010955, 2010956, 2026848, 2026849, 2026852, 2066860, 2010928, 2010955, 2010956, 2026848, 2026849, 2026852, 2066860, 2098782, 2145226, 253009-SC, 253035-SC, 253066-SC, 253089, 253123, 253139, 253160, 253178, 253197, 253213, 253241, 253265, 253285, 253303, 253310, 253325, 253337, 253360, 253386, 253403, 253405, 253427, 253449, 253463, 857-SC1; B7928: 213167, 233061-SC, 253045-SC, 253055-SC, 253059-SC, 253077-SC, 253082-SC, 253086, 253093, 253095, 253102, 253111, 253118, 253129, 253137, 253145, 253151, 253158, 253173, 253176, 253186, 253193, 253201, 253206, 253209, 253218, 253220, 253230, 253232, 253239, 253248, 253252, 253256, 253260, 253268, 253277, 253287, 253291, 253296, 253306, 253312, 253317, 253323, 253330, 253334, 253340, 253345, 253349, 253353, 253359, 253368, 253371, 253382, 253389, 253393, 253398, 253404, 253408, 253416, 253424, 253429, 253433, 253442, 253448, 253454, 253460, 253464, 253471, 253478, 253483, 253488, 253494, 253497, 253501, 253507; B7932: 2010961, 2012567, 2012965, 2022800; B7937: 253355, 253362, 253377, 253394; B7938: 253354, 253361, 253378, 253395; Z0125: 78-458-YJ; Z8015: 59-941-SN, 61-164-LA, 61-898-LA, 62-799-R5, 63-307-YJ, 64-027-2A, 64-245-K4, 65-616-K4, 66-136-R5, 67-582-YJ, 67-803-2A, 69-758-R5, 70-155-K4, 71-538-LA, 73-027-YJ, 73-736-YJ, 74-402-K4, 74-962-R5, 76-203-2A, 77-360-R5, 80-869-R5, 80-957-K4, 85-657-LA, 88-569-2A, 89-613-SN, 92-782-R5, 94-196.2A, 94-196-2A; Z8017: 61-577-K4, 63-347-SN, 64-194-2A, 64-407-K4, 68-446-K4, 70-351-2A, 72-636-YJ, 73-735-YJ, 74-585-K4, 78-846-2A, 81-540-2A, 84-591-YJ, 86-016-SN, 89-540-LA, 91-210-LA, 92-295-YJ, 92-781-R5, 93-166-LA; Z8028: 57-112-R5, 58-440-LA, 62-236-R5, 62-239-R5, 63-308-YJ, 64-028-2A, 65-333-LA, 65-617-K4, 66-352-R5

1. Exodus(TM) 8F (2.7 mm)/ 35 cm Standard Loop Biliary Drainage Catheter with Hydrophilic Coating, REF/ Catalog No. 10005, UPN/Product No. H965100051, STERILE --- Package/Box Units: Box of 5 eaches --- Made in USA. The Exodus Drainage Catheter consists of a radiopaque polyurethane catheter. The distal end of the catheter is configured as a J-Tip or a locking pigtail and is coated with a hydrophilic coating. Catheter markings are provided in centimeters on the shaft to indicate the distance from the distal tip. The Exodus Biliary Drainage Catheter includes a radiopaque (RO) marker band located approximate 5 mm from the most proximal drainage hole to assist with catheter placement. Biliary Drainage Catheters are intended for percutaneous drainage of the biliary tree. Recall # Z-0647-2012;
2. Exodus(TM) 10 F (3.4 mm)/ 35 cm Standard Loop Biliary Drainage Catheter with Hydrophilic Coating, REF/Catalog No. 10013, UPN/Product No. H965100131, STERILE --- Package/Box Units: Box of 5 each --- Made in USA. The Exodus Drainage Catheter consists of a radiopaque polyurethane catheter. The distal end of the catheter is configured as a J-Tip or a locking pigtail and is coated with a hydrophilic coating. Catheter markings are provided in centimeters on the shaft to indicate the distance from the distal tip. The Exodus Biliary Drainage Catheter includes a radiopaque (RO) marker band located approximate 5 mm from the most proximal drainage hole to assist with catheter placement. Biliary Drainage Catheters are intended for percutaneous drainage of the biliary tree. Recall # Z-0648-2012

1. Lots: 1ML0052506, 1ML0062201, 1ML0080901;
2. Lots: 1ML0060705, 1ML0070901, 1PD0040501

1. Weck, DuraHook (6mm) and (12mm), Neuro Elastic Retractors, 6 per Package, 10 Packages per Sales Units, 10 Sales Units per Shipper, Rx Only. For use as skin retraction devices during general surgery. DuraHooks are also cleared for use in procedures requiring retraction of dura mater. Catalog numbers: 382800. Recall # Z-0677-2012;
2. Weck, DermaHook(12mm), Neuro Elastic Retractors, 6 per Package, 10 Packages per Sales Units, 10 Sales Units per Shipper, Rx Only. For use as skin retraction devices during general surgery. DuraHooks are also cleared for use in procedures requiring retraction of dura mater. Catalog number: 382805. Recall # Z-0678-2012

1. Lot numbers: 01A1100009, 01A1100165, 01A1100251, 01A1100355, 01B1100028, 01B1100274, 01E1000297, 01F1000587, 01F1000588, 01F1000589, 01G1000138, 01G1000327, 01G1000433, 01G1000512, 01H1000112, 01H1000297, 01J1000548, 01K1000182, 01M1000218, 01M1000326 and 01M1000339;
2. Lot numbers: 01A1100470, 01A1100374, 01A1100517, 01A1100519, 01B1100006, 01B1100131, 01B1100159, 01B1100275, 01E1000026, 01F1000586, 01G1000137, 01G1000139, 01G1000251, 01G1000326, 01H1000271, 01H1000296, 01J1000267, 01J1000298, 01K1000005, 01K1000051, 01K1000181, 01K1000334, 01L1000282, 01L1000283, 01L1000292, 01M1000008, 01M1000144, 01M1000198, 01M1000199 and 01M1000200

1. 37% Etching Gel-1ml syringe, part # T06 The intended use of these devices is to etch tooth dentin/enamel in order to prepare the tooth surface prior to the application of a bonding agent. Recall # Z-0153-2012;
2. 37% Etching Gel-1ml syringe 20 pk, part # T06A The intended use of these devices is to etch tooth dentin/enamel in order to prepare the tooth surface prior to the application of a bonding agent. Recall # Z-0154-2012;
3. 37% Etching Gel-1ml syringe 50 pk, part # T06B The intended use of these devices is to etch tooth dentin/enamel in order to prepare the tooth surface prior to the application of a bonding agent. Recall # Z-0155-2012;
4. 37% Etching Gel-3ml syringe, part #N01H The intended use of these devices is to etch tooth dentin/enamel in order to prepare the tooth surface prior to the application of a bonding agent. Recall # Z-0156-2012;
5. 37% Etching Gel-5ml syringe, part #N01IB The intended use of these devices is to etch tooth dentin/enamel in order to prepare the tooth surface prior to the application of a bonding agent. Recall # Z-0157-2012