Recalling Firm
Stryker Instruments Div. of Stryker Corporation
Vitamin Cottage Natural Food Markets, Inc.

Initial Firm Notification of Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Distribution Pattern
Worldwide - United States Nationwide Distribution and the countries: Argentina, Belgium, Chile, Cyprus, Denmark, Ecuador, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Malaysia, Netherlands, Norway, Panama, Poland, Portugal, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, Spain, Sweden, Switzerland, Thailand, Turkey, UAE and United Kingdom.
Worldwide Distribution - US (nationwide) and Internationally to Australia, Belgium, Brazil, China, Colombia, Croatia, Czech Republic, Ecuador, Finland, France, Germany, Hong Kong, India, Israel, Japan, Mexico, Netherlands, Peru, Poland, Portugal, Romania, Russia, Serbia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand and United Arab Emirates.
Nationwide Distribution including FL, IL, NV, NJ, OH, and TN.
Nationwide Distribution-including the states of FL, IA, IL, IN, LA, MD, MN, MO, NC, NM, NY, PA, TN, TX, VA, and WI.
Worldwide - US Nationwide Distribution and the countries of Australia and Canada.
Nationwide Distribution and Internationally to Canada and Switzerland.
US Nationwide Distribution in the states of: UT, CA, FL, TX, MA, GA, OK, VA, CT, OK, and WY.
The product was distributed to Sams Club Distribution Center, located at 1325 Central Ave, University Park, IL 60484.
Domestic: None. International: Netherlands and Japan
Product was shipped to the following states: CA, CO, FL, GA, IL, IN, KY, LA, MD, MI, MO, NY, OH, TN, TX & WI.
Us Nationwide Distribution in the state ID including PR.
Nationwide Distribution to Florida only.
Nationwide Distribution including GA, CT and PA.
US Distribution to the states of : CA, IL, MN, MO, OR, IL, UT RI, MA, WA, NE, NY, NJ, TX and WI.
Distributed in the states of FL, GA, IL, NY, TX, and WA.
Worldwide Distribution - US Nationwide in the states of NC, IN, PA, OH and the country of the Netherlands.
Worldwide distribution. US states of NC and AK; Taiwan, Japan, and Germany.
Domestic: TX NJ, NC, KY, MA, SD, MO, AL, IN, GA, AR International: Netherlands, Japan, Costa Rica
Worldwide Distribution-US (nationwide) and the countries of Australia, Austria, Belgium, Canada, Finland, France, Germany, Greece, Hong Kong, Hungary, Italy, Luxembourg, Netherlands, New Zealand, Norway, Portugal, South Africa, Spain, Switzerland, and United Kingdom.
US Nationwide Distribution in the states of CA, MO & WI
US Nationwide Distribution in the states of AZ, CA, CO, FL, IL, MI, MN, NC, NJ, NV, PA, TN, TX, UT, WA and WV.
Worldwide Distribution - US including AZ, CA, GA, ID, IL, MO, NJ, NY, NC, OR, SC, TN, WV, and Internationally to Austria, Brazil, Bulgaria, Canada, Colombia, Germany, Israel, Italy, Japan, Mexico, Russia, Taiwan, and Venezuela.
Nationwide Distribution including AR CA CO CT FL GA IA IL IN KS KY LA MA MD ME MO MS NC NE NJ NY OH PA SC TX VA WA WY.
Worldwide Distribution - US (nationwide) and Internationally to AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SK, AE, AR, AU, AZ, BD, BH, BR, BY, CA, CL, CN, CO, CR, DZ, EC, EG, ET, GE, GY, HK, ID, IL, IN, IQ, IR, JO, JP, KR, KW, KZ, LB, LK, LY, MA, MN, MU, MX, MY, NG, NP, NZ, OM, PA, PE, PH, PK, PR, PS, QA, RE, RU, SA, SG, SV, SY, TH, TN, TR, TT, TW, UA, VN, ZA.
US Distribution to the states of : NJ, VA, OH, IN, MI, FL, WI, CA, TN, MD, NC, WA, UT, ID, MO, NV and KS.
Nationwide to Washington, Oregon, Idaho, Montana, Wyoming, Nevada, Utah, Arizona, New Mexico, Colorado, Texas, Oklahoma, Kansas, Nebraska, Missouri, Arkansas. No foreign/govt/VA/military consignees.
Nationwide Distribution including OH, FL, IL, TX, OH, NY, AZ, and NJ.
Nationwide, Puerto Rico, Guam, Canada and Singapore

Product Description
Grassplot Ginger Slice, NET WT. 3.5 OZ. (100g) , UPC 7246 6247, PRODUCT OF CHINA --- Firms on label: Manufactory: Grassplot Foodstuff Factory ADD: Huangshan Road, Huangshan Mansion, suite 417 Shantou, Guangdong, China -- Distributed by: LION PAVILION LIMITED --- Nutrition Facts: Serving Size 25 g Servings Per Container 4 --- The product is packaged in a clear plastic bottle.
Blood and Blood Products for Reprocessing
Red Blood Cells (Apheresis) Leukocytes Reduced
Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated
Plasma Frozen Within 24 Hours After Phlebotomy (FP24)
Platelets Pheresis Leukocytes Reduced Irradiated
Red Blood Cells Leukocytes Reduced Irradiated
Breas Vivo 50 Home Care Ventilator Product Usage: Respiratory Care
NDI Disposable Reflective Marker Spheres for Brainlab IGS system. Product Usage: Disposable reflective marker spheres are attached to reference arrays and instruments, thus enabling the infrared tracking systems to detect the position of the patient and instruments in the surgical field.
The FLOW-i Anesthesia System Axillary O2 and Suction Module, Device Part number: 66 79 847 FLOW-i Anesthesia System: Is indicated for administering inhalation anesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting patients with a limited ability to breathe.The system is intended for use in a wide range of population: from neonatal to adult patients. The system is intended for use in hospital environments, except for the MRI environment, by healthcare professionals trained in inhalation anesthesia administration. Auxiliary O2 and Suction Module: Is an option available for the FLOW-i Anesthesia System. The module contains two main parts: Flowmeter unit: The intended use of the flowmeter is to provide oxygen for patient therapy. Suction unit: The intended use is to extract body fluids from the stomach and airways.
Autopen Classic Automatic insulin delivery pen, 3.0ml x 2 unit 2-42 units, AN3800, Lot 7JH, NDC 08470-3800-01, The product is a non-sterile automatic subcutaneous injection device which delivers insulin.
Tortilleria Provincia Refrigerate After Purchase White Corn Tortillas, Net Wt. 16 oz, 0 89780 10000 1 & 64 oz, 0 89780 10001 8, Tortilleria Provincia, 1200 B Clay St. Bowling Green, KY 42101 (270) 842-7733
Tortilleria Provincia Refrigerate After Purchase Yellow Corn Tortillas, Net Wt. 16 oz, 0 89780 10000 1 & 64 oz, 0 89780 10001 8, Tortilleria Provincia, 1200 B Clay St. Bowling Green, KY 42101 (270) 842-7733
Tortilleria Provincia Refrigerate After Purchase Blue Corn Tortillas, Net Wt. 16 oz, 0 89780 10000 1 & 64 oz, 0 89780 10001 8, Tortilleria Provincia, 1200 B Clay St. Bowling Green, KY 42101 (270) 842-7733
0210-312-000-Woundcare Replacement kit with soft tip; 0210-318-000; Woundcare Replacement with fan tip; 0210-318-100- Woundcare Replacement Kit; 0210-318-200-Woundcare Replacement with retract coax tip. Accessory to Stryker InterPulse Irrigation System, used for wound debridement, soft tissue debridement, and cleansing of medical, clinical, or surgical sites.
Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis
Dr. Praeger's California Veggie Burgers Gluten Free 11 oz. Manufactured by Dr. Praeger's Sensible Foods Elmwood Park, NJ 07047 www.drpraegers.com Made in the USA UPC 080868000602
Apex ARC Hip Stem, HA Coated, Size 5; Product Code: HC-21005-HA Product Usage: The Apex ARC Hip Stem is the femoral component of a primary or revision total hip replacement. This femoral hip stem is intended for press-fit application and is provided sterile for single use. They are manufactured from titanium alloy. The stem has a proximal porous coating of titanium plasma spray under a coating of hydroxyapatite (HA)
Rifampin for Injection, USP 600mg/vial in a 20mL vial, Rx only, Manufactured for Fresenius Kabi LLC 3 Corporate Drive, Lake Zurich, IL, 60047, by Fresenius Kabi LLC, 2020 N Ruby Street, Melrose Park, IL 60160. NDC 63323-351-20
CapriSun Variety Pack, with a multi colored plastic wrap with white and yellow lettering, covering 4 cartons. The 4 cartons consist of fruit punch (the effected product), wild cherry, pacific cooler, and strawberry kiwi.Fruit Punch Flavored Juice Drink Blend in a blue box with white lettering and fruit pictures. The carton contains 10,6 oz pouches.
A.L.P.S., 3.5mm x 60 mm Cortical Locking Screw. Bone fixation screw.
Baked Samosa Sweet Potato (Baked Indian pastry with a savory filling), Frozen package, Net wt. 7.5 oz., No UPC
Del Campo Alino Casero Seasoning Paste, 15oz; Product Code: 03138; UPC: 7 751227 000894. Product is in a glass bottle.
Diet Bubba Cola, 20 FL. OZ (1.25 PT) 591 mL INGREDIENTS: CARBONATED WATER, HIGH FRUCTOSE CORN SYRUP, CARAMEL COLOR, PHOSPHORIC ACID, NATURAL FLAVOR, CAFFEINE. DISTRIBUTED BY: SAVE-A-LOT FOOD STORES, LTD. EARTH CITY, MO 63045 0 51933 34484 6
Helical Blade Inserter for Trochanteric Fixation Nail-ADVANCED (TFNA); intended to secure the head element to the head element inserter to prevent disengagement during head element insertion. Manual orthopedic surgical instrument.
G7 Variant Elution Buffer HiS no. 1 (M) component of the Tosoh Automated Glycohemoglobin Analyzer HLC 723G7. Product Usage: G7 Variant Elution Buffer HiS No 1. (M) is one of the buffers used on Tosoh Automated Glycohemoglobin Analyzer HLC 723G7.
Exactech Ambassador Cervical Plate System The Exactech Ambassador Cervical Place System is intended for anterior cervical fixation (C2-T1) for the following: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
Exactech Single Barrel Drill Guides The Single Barrel Drill Guide is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.
BD Flow Cytometers; used on all BD FACSCount, BD FACSCalibur, BD FACSCanto, BD FACSCanto II, BD LSR II, BD LSRFortessa,BD FACSAria, BD FACSAria II, BD FACSAria Ill, BD lnflux, BD FACSArray,BD Pathway 855, BD Pathway 435 and all SORP instruments. BD Biosciences Flow cytometers for the enumeration of tissue and biological fluid samples such as blood and blood components.
Etac Supporter toilet armrest Etac Supporter toilet armrests are foldable and have comfortable rounded grips for the hands. Supporter is simple to mount without the need for any tools. It fits both floor and wall mounted toilets. If space around the toilet is limited either armrest can easily be detached. Supporter includes seat ring and lid.
Dual Delivery 4DD-1 of GYC-1000 Green Laser Photocoagulator system GYC4DD-1: The Nidek Green Laser Photocoagulator Model GYC- 1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.
Endophotocoagulation Delivery 4EP-1 of GYC-1000 Green Laser Photocoagulator System; GYC4EP-01 0W02 and GYC4EP-1 0Z20; The Nidek Green Laser Photocoagulator Model GYC- 1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.
Altiva / Exactech Spine, Large Set Screw, Catalog Number 28202, Lot Number AS05107. Intended to provide immobilization and stabilization of spinal segments.
Oxford Femoral Drill Guide Lateral IM Adapter Product Usage: Drill guide. The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. Partial replacement of the articulating surfaces of the knee when only one side of the knee joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous partial arthroplasty in the affected compartment. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.
ZNN Antegrade Femoral Nail (ZNN AF). Orthopedic internal fixation device.
Project 7 CARAMEL APPLE Sugar Free Gum, approximately 32 lbs. -- Manufactured by: Ford Gum and Machine Company, 18 Newton Ave., Akron, New York 14001 --- The product was supplied in cardboard bulk boxes. with a label reading, ''Project 7 CARAMEL APPLE, approximately 32 pounds Sugar Free Gum''. Each gum piece is 1.35 g coated tablet. Ford gum produce a raw center, which gets coated, inspected and packed into the cardboard bulk boxes.
Sysco International Whole Segments Mandarin Oranges In Light Syrup Net Wt. 6 LB 10 OZ (3.01 kg) NDC: 074865629065; 6 cans per case
Sour Caramel Apple Chewing, net wt .53 oz, Gum UPC 844911 002919. Sour Caramel Apple chewing gum tablet packed in 12ct metalized PET Pouch with zipper.
Abutment Retrieval Instrument Zirconia CC RP/WP, Article No. 37882 and Abutment Retrieval Kit, Article No. 37508 (Article No. 37882 was assembled in this kit). Used to remove a zirconia abutment if the abutment is stuck in the implant connection due to a tight seat. Endosseous dental implant instrument.
Patient Handling System (Motion Control Software), Product Usage: Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
Allofix Insertion Kit, 2.0 mm, Single Drill, Product Usage: MTF Surgical Instruments are designed for the specific needs of the orthopedic surgeon and are intended to be used in conjunction with the associated allograft. This kit is for single use only.
MOSAIQ Oncology Information System MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.
Alere i flu, Alere i, Alere Influenza A & B; Part Number (PN) 425-024 The Alere'' i Influenza A & B assay, performed on the Alere'' i Instrument, is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection and discrimination of influenza A and B viral RNA in nasal swabs from patients with signs and symptoms of respiratory infection. It is intended for use as an aid in the differential diagnosis of influenza A and B viral infections in humans, in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus.
Sorin Stockert Heater-Cooler 3T, 230 V Temperature control for extracorporeal perfusion of durations up to 6 hours.
Sorin Stockert Heater-Cooler 3T, 240 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
Sorin Stockert Heater-Cooler 3T, 208 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
Sorin Stockert Heater-Cooler 3T, 127 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
Sorin Stockert Heater-Cooler 3T, 120 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
Sorin Stockert Heater-Cooler 3T, 200 V / 50Hz / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
16mm Chisel Blade; used in the LCP Anterior Ankle Arthodesis Plate System and the Hip Preservation Surgery Set. Orthopedic manual surgical instrument.
IMPAX Agility. IMPAX Agility when deployed as a departmental Picture Archiving and communications system (PACS) provides an interface for the acquisition, display, digital processing, annotation, review, printing, storage and distribution of multimodality medical images, reports and demographic information for diagnostic purposes within the system and across computer networks.
Natural Grocers Caribbean Fruit & Nut Mix, Net Wt. (10 oz) (283g), packaged in plastic bag.
RadiForce GX540, 5MP Monochrome LCD Monitor, Part Code No. 0FTD1826A5, 0FTD1826B5, 0FTD1826C5, UPC 690592034752. This product is intended to be used in displaying and viewing digital images including those of digital mammography for review and analysis by trained medical practitioners.
RadiForce RX650, 6MP Color LCD Monitor, Part Code No. 0FTD1957A5, 0FTD195B5, UPC 690592037203. This product is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners. It does not support the display of mammography images for diagnosis.
RadiForce RX850, 8MP Color LCD Monitor, Part Code No. 0FTD1958A2, UPC 690592037180. This product is intended to be used in displaying and viewing digital images those of digital mammography for review and analysis by trained medical practitioners.
0.9% Sodium Chloride Injection USP, 50 mL ADD-Vantage Unit, Rx only, Manufactured by Hospira, Inc., Ausitn, TX 78728, NDC 00409-7101-68
Desmopressin Acetate Tablets, 0.1 mg Tablets, Rx Only, Packed in 30 Tablet (3 x 10) Cartons. Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217. NDC: 68084-606-21.
HydrOXYzine Hydrochloride Tablets, USP 25 mg, Rx only, 100 count (NDC 0603-3968-21), 500 count (NDC 0603-3968-28) and 1000 count (NDC 0603-3968-32) bottles, Manufactured for Qualitest Pharmaceuticals, Huntsville, AL
Nitroglycerin Transdermal System 0.2 mg/hr (10 cm2), For Transdermal Use Only, 30 Systems (patches) per box, Rx Only, Manufactured for: Kremers Urban Pharmaceuticals Inc., Princeton, NJ, 08540, USA, By LTS Lohmann Therapie Systeme AG, Anderach, Federal Republic of Germany, NDC 62175-123-01
Nitroglycerin Transdermal System 0.4 mg/hr (18 cm2), For Transdermal Use Only, 30 Systems (patches) per box, Rx Only, Manufactured for: Kremers Urban Pharmaceuticals Inc., Princeton, NJ, 08540, USA, By LTS Lohmann Therapie Systeme AG, Anderach, Federal Republic of Germany, NDC 62175-124-01
KETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3795-01 --- Also labeled under NOVAPLUS label NDC 0409-3795-49
KETOROLAC Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3796-01 ---- ALSO labeled under NOVAPLUS label NDC 0409-3796-49

Code Info
All Vivo 50 Ventilators (215000, 215016) with firmware version 2.04
1) Catalog Number: 41773 (90 pack) All Lots beginning with the prefix C / All expiration dates; 2) Catalog Number: 41774 (270 pack) All Lots beginning with the prefix C / All expiration dates; and 3) Catalog Number: 41813 (60 pack) All Lots beginning with the prefix C / All expiration dates
Case Lot F15BC-04A Retail Box Lot # F15BC
code date: 27 MAY 2016 UPC code for the case: 087684004449 UPC code for the carton of Fruit Punch Flavored Juice Drink Blend: 087684001073
Part Number Lot Numbers 03.037.024 T102759
Catalog Number 28202, Lot Number AS05107
Product Code: 900920, Serial #:906912041001, Expiry date 01Mar2017
Lot Number 0073853 (US distribution only)
Product code 16-02-80 Serial number 16S10027-16S15641
Product code 16-02-81 Serial number 16S10743-16S11708
Product code 16-02-82 Serial number 16S10772-16S15523
Product code 16-02-83 Serial number 16S11455-16S15190
Product code 16-02-85 Serial number 16S10958-16S15634
Product code 16-02-95 Serial number 16S12004-16S15385

Product Quantity
1, 056 cases, 4 cartons per case, 10 pouches per carton.
12,460,975 vials(Hospira label); 3,016,500 vials (NOVAPLUS label)
5,214,900 vials (Hospira label); 250,600 vials (NOVAPLUS label)

Reason for Recall
The product contained undeclared sulfites (735 ppm) based on sampling and analysis by New York State Department of Agriculture & Markets.
Blood products, collected from ineligible donors, were distributed.
Unintended treatment termination could result from a keypad malfunction in some situations. The device erroneously interprets this as a Stop Treatment Instruction. An alarm will not sound, or be registered. Accessories and monitoring equipment connected to the Vivo 50 will stop functioning as the device enters stand-by mode.
Inadequate curing of adhesive, may cause the two halves of the spheres to separate.
Maquet has identified that in some FLOW-i Anesthesia System Auxiliary O2 and Suction Modules, the suctioning function cannot be activated or controlled by the suction unit on/off switch leading to a decrease or loss of suctioning capability of the modules.
The dials in the Autopens are not working - the dial does not stay dialed, but springs right back to 0. As a result, the patient could not dial up a dose of medicine to deliver via an injection.
The firm used the same label clear plastic bags with Nutrition Facts and Ingredients listed for all three type corn tortillas (Yellow, White, and Blue); the color Yellow # 2 was written in lieu of Yellow # 6 for the Blue corn tortilla; additional color ingredients (FD&C BLUE No. 1, FD&C YELLOW No. 2, FD&C RED N. 40, SODIUM BENZOATE) are included for the White and Yellow corn tortillas.
Stryker Instruments is voluntarily recalling the WoundCare Replacement kits for a potential sterility breach in the packaging.
Blood products, collected from a donor whose suitability to donate was not fully documented, were distributed.
Inadequate curing of adhesive, which may cause the two halves of the spheres to separate.
Platelet products, collected on an instrument that failed the leukoreduction quality control process, were distributed.
It was reported that the RIA Drive Shaft, Tube Assembly, and Reamer Head have the potential to break when incorrectly assembled or used improperly. Precautionary statements are being added to the Reamer / Irrigator / Aspirator (RIA) Surgical Technique Guide.
Dr. Praeger's Gluten Free California Burgers contain undeclared soy.
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
Product may breach the inner and outer sterile pouches during shipping or handling.
Failed impurities/degradation specifications; two lots are out-of-specification for impurities and color
Possible brass fragments in Capri Sun Fruit Punch Flavored Juice Drink Blend.
Sterile packaging was not sealed. The implantation of an unsterile screw may lead to infection.
Indian pastry Baked Samosa (sweet potato) is recalled due to undeclared soy lecithin. The firm used a pan release Canola cooking oil spray which contains soy lecithin but finished product's label does not declare soy.
Product contains undeclared preservatives, Benzoic Acid and Sorbic Acid.
The firm was notified by one of it's retail stores that the ingredient statement does not declare citric acid, potassium benzoate, aspartame, and acesulfame potassium. The product contains the label for a regular drink instead of a diet drink.
The height of one of the three guiding pins of the Helical Blade Inserter for the TFNA is oversized. The Helical Blade Inserter is therefore unable to pass through the Blade/Screw Guide Sleeve (part 03.037.017).
The G7 Variant Elution Buffer HiS no. 1 (M) is incorrectly labeled with an expiration date of October 2015. The correct expiration date is October 2014.
Shipped to a single consignee prior to completion of final inspection.
Instruments installed between June 2007 and September 2011 do not contain labeling pursuant to the Food and Drug Administration's (FDA's) Guidance on Laser Products- Conformance with IEC 60825-1 and IEC 60601-2-22 (Laser Notice No. 50).
The Supporter toilet armrest has two Fast Nuts fixing the product to the toilet porcelain. The firm has reports of the two Fast Nuts coming loose and causing the Supporter to become unsteady.
Accessories to the GYC-1000 laser were missing Laser Aperture labels.
Oxford Femoral Drill Guide Lateral IM Adapter may have an undersized diameter that can cause an interference with PN: 32-422822, Oxford Microplasty IM Link.
A single distributed ZNN Greater Trochanter Femoral Nail may have been dented. Potential for fatigue of implant prior to sufficient fracture healing, which may result in need for implant removal and revision of fracture fixation to assure proper healing and avoid fracture malunion or nonunion.
The bulk Project 7 Caramel Apple Sugar Free Gum contains undeclared milk from a caramel ingredient used in production.
Product tested positive for Carbendazim.
Project 7 is recalling all lots of Sour Caramel Apple Chewing Gum because the caramel flavoring ingredient in the gum contains undeclared milk.
Medium Bone Plate Forceps was assembled with the incorrect grip arm tip. Potential that the surgeon will be unable to provisionally clamp the plate to the patient's bone.
Nobel Biocare is recalling the Abutment Retrieval Instrument Zirconia CC RP/WP because an internal investigation showed that one dimension of the affected instrument is incorrect. Therefore this instrument cannot be used to remove the metal adapter as intended.
ViewRay'' received a report that the couch moved unexpectedly into the bore after performing a RTCS reboot.
Musculoskeletal Transplant Foundation is recalling a certain lot of Allofix Insertion Kits because they are labeled as having a 2.0mm diameter drill however it may contain a 2.4 mm diameter drill.
A problem exists in MOSAIQ resulting in the incorrect field size being sent to the treatment machine for stereotactic plans using cones.
Risk of false negative results due to microbial growth in the Sample Receiver of one lot of the Alere i Influenza A & B kit
Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if proper disinfection and maintenance is not performed per Instructions for Use.
It was discovered that a 10mm Chisel Blade was etched as a 16mm Chisel Blade.
Firm received a complaint that the hospital had sent two accession numbers over the same morning and on the Agility side the patient name was incorrect.
Vitamin Cottage Natural Food Markets, Inc is recalling one lot of Natural Grocers brand Caribbean Nut & Fruit Mix as the product contains macadamia nuts that have the potential to be contaminated with Salmonella.
EIZO is recalling the RadiForce LCD Monitors could display abnormally while connecting to particular graphics boards with DisplayPort.
Lack of assurance of sterility: Potential channel leaks near the threaded vial port.
Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side.
Failed Tablet/Capsule Specifications; The identification codes on some tablets may be unreadable
Failed Impurities/Degradation Specifications: failed specification for unknown impurity at the 24 month stability testing.
Failed Impurities/Degradation Specifications: Two lots failed specification for unknown impurity at the 24 month stability testing.
Crystallization; identified as calcium salt of Ketorolac