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Showing 22601–22620 of 29086 results

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Cyproheptadine HCl Syrup (Pharmaceutical Associates) – Impurity Issue (2014)

Failed Impurities/Degradation Specifications : Out-of-specification result for an unidentified impurity at the 12 month stability test point.

Class IIModerate

FDAOct 16, 2014Nationwide• Pharmaceutical Associates Inc

Asian Mix (Publix) – Undeclared Peanuts (2014)

Product contains peanuts that are not declared on the label.

Class IIModerate

FDAOct 16, 2014AL, FL, GA +3 more• Publix Bakery Plant

Zimmer Patient Specific Instrument (Materialise) - Incorrect Guides (2014)

The box of guides for a specific case arrived intact but contained two (2) femoral guides instead of one (1) femoral guide and one (1) tibial guide. The device did not meet specification: One tibia guide missing and one femur guide contained an edge which was +0.04 mm over specification.

Class IIModerate

FDAOct 16, 2014Nationwide• Materialise USA LLC

Asian 7 Rice Cracker Mix (United Natural) – Peanut Contamination (2014)

A peanut fragment was discovered in a carton of 22lb. Asian 7 Rice Cracker Mix.

Class IIModerate

FDAOct 16, 2014CT, FL, ME +3 more• United Natural Trading

Market Basket Rice Cracker Mix (United Natural) – Peanut Fragment (2014)

A peanut fragment was discovered in a carton of 22lb. Asian 7 Rice Cracker Mix.

Class IIModerate

FDAOct 16, 2014CT, FL, ME +3 more• United Natural Trading

Align Radial Stems (Skeletal Dynamics) - Stem Fracture (2014)

Report received where the Align Radial Stem fractured.

Class IIModerate

FDAOct 16, 2014Nationwide• Skeletal Dynamics

MicroVue Bb Plus EIA (Diagnostic Hybrids) - Incorrect Quantitation (2014)

Samples are quantitating incorrectly, with approximately 50% higher concentration values than previously reported and historically documented.

Class IIModerate

FDAOct 16, 2014AL, CO, CT +8 more• Diagnostic Hybrids Inc

AMS Monarc Subfascial Hammock (AMS) - Packaging Concern (2014)

During routine periodic packaging testing, AMS identified that in simulated extreme shipping and handling situations the sterile barrier packaging of the Needle Passer components supplied with the AdVance" Male Sling System; Model # 720088-01; AdVance" XP Male Sling System; Model # 720163-01; Monarc" C Subfacial Hammock; Model # 72404195; Monarc" + Subfacial Hammock; Model #

Class IIModerate

FDAOct 15, 2014Nationwide• American Medical Systems, Inc.

Mango Gelatin Mix (U.B.C Distributors) – Undeclared Colors (2014)

Undeclared Allergen

Voluntary recall of strawberry flavored gelatin mix and mango flavored gelatin mix which were found to contain undeclared colors, FD& C Red # 40, FD&C Yellow #5, and FD&C Yellow #6.

Class IIModerate

FDAOct 15, 2014AZ, CA, CO +29 more• U.B.C Food Distributors, LLC

ATTUNE Intuition Distal Femoral Jig (DePuy) - Potential Displacement (2014)

Issuing a device correction because if the pin bushing is over loaded or inverted, there is the potential for partial or full displacement and fracture of the plastic around the pin bushing.

Class IIModerate

FDAOct 15, 2014Nationwide• DePuy Orthopaedics, Inc.

AdVance Male Sling System (AMS) - Packaging Concern (2014)

During routine periodic packaging testing, AMS identified that in simulated extreme shipping and handling situations the sterile barrier packaging of the Needle Passer components supplied with the AdVance" Male Sling System; Model # 720088-01; AdVance" XP Male Sling System; Model # 720163-01; Monarc" C Subfacial Hammock; Model # 72404195; Monarc" + Subfacial Hammock; Model #

Class IIModerate

FDAOct 15, 2014Nationwide• American Medical Systems, Inc.

AlignRT (Vision Rt) - Interlock Failure (2014)

Potential failure of AlignRT to assert interlock.

Class IIModerate

FDAOct 15, 2014CA, IN, MN +2 more• Vision Rt Inc

Strawberry Gelatin Mix (U.B.C Distributors) – Undeclared Colors (2014)

Undeclared Allergen

Voluntary recall of strawberry flavored gelatin mix and mango flavored gelatin mix which were found to contain undeclared colors, FD& C Red # 40, FD&C Yellow #5, and FD&C Yellow #6.

Class IIModerate

FDAOct 15, 2014AZ, CA, CO +29 more• U.B.C Food Distributors, LLC

Tri-mix #4 (Vann) – Sterility Concerns (2014)

Lack of Assurance of Sterility: A recent FDA inspection of Vann Healthcare Services facility revealed deficiencies that raise concerns about the pharmacy's ability to consistently assure sterility of their products.

Class IIModerate

FDAOct 14, 2014KY• Vann Healthcare Services Inc

Normosol-R Electrolytes (Hospira) – Potential Container Leak (2014)

Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.

Class IIModerate

FDAOct 14, 2014Nationwide• Hospira Inc.

Lactated Ringer's Dextrose (Hospira) – Potential Container Leak (2014)

Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.

Class IIModerate

FDAOct 14, 2014Nationwide• Hospira Inc.

Dextrose Sodium Chloride Injection (Hospira) – sterility risk (2014)

Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.

Class IIModerate

FDAOct 14, 2014Nationwide• Hospira Inc.

Trabecular Metal Tibial Impactor (Zimmer) - Assembly Instructions (2014)

To provide clarifying instructions relating to the assembly/disassembly of the Trabecular Metal Tibial Impactor with/from TM tibial Impactor Pads due to complaints regarding Tibal Impactor pad fracture.

Class IIModerate

FDAOct 14, 2014Nationwide• Zimmer, Inc.

GE Healthcare Infinia (GE Healthcare) - System Safety Issue (2014)

GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to the gantry. GE is updating the Preventative Maintenance procedure and schedule, and added an additional Preventative Maintenance check for loose fasteners on the Nuclear Medicaine systems.

Class IIModerate

FDAOct 14, 2014Nationwide• GE Healthcare, LLC

Fixed Curve Response Electrophysiology Catheter (St Jude) - Specific Batch (2014)

St. Jude Medical is performing a voluntary recall of batch 4671318, model number 401353 of the Response Fixed Curve DECA 6F 65cm CSL 2/8 Catheter. Specifically, the firm has identified that every device packaged within batch 4671318 contains the incorrect catheter (Supreme FC QUAD 5F catheter) within the packaging. To date, no serious injuries have occurred as a result of this issue

Class IIModerate

FDAOct 14, 2014CA, GA, NJ +3 more• St Jude Medical

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