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Showing 22801–22820 of 29086 results

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Amerigel Hydrogel Wound Dressing (Amerx) – Formulation Deviation (2014)

Formulation deviation

Class IIModerate

FDASep 26, 2014Nationwide• Amerx Health Care Corp.

Diclofenac-Misoprostol Tablets (Actavis) – Tablet Defect (2014)

Failed Tablet/Capsule Specifications: Presence of split or broken tablets.

Class IIModerate

FDASep 26, 2014Nationwide• Actavis Laboratories, FL, Inc.

Freedom EVO-2 100 Base Unit (Tecan) – Liquid Aspiration Error (2014)

Distortion (noise interference) of the liquid level capacitance can result in air aspiration instead of liquid aspiration. This might cause a false signal (air detection) with possible dispense errors resulting in erroneous results.

Class IIModerate

FDASep 26, 2014IL• Tecan US, Inc.

Amerigel Saturated Gauze Dressing (Amerx) – Formulation Deviation (2014)

Formulation deviation

Class IIModerate

FDASep 26, 2014Nationwide• Amerx Health Care Corp.

Pillsbury Biscuits Buttermilk (General Mills) - Undeclared Milk (2014)

Undeclared Milk

Undeclared Milk ingredient on retail package. In error, individually wrapped packages of Pillsbury Biscuits Buttermilk were placed into Pillsbury Biscuit Flaky layers overwrap to make the 4pk. The individual packages of the product are labeled correctly however the overwrap is not the correct product.

Class IIModerate

FDASep 26, 2014CT, IA, ME +6 more• General Mills, Inc.

Pilling Knife Handles (Teleflex) – Improper Fit (2014)

The knife handles slot depth is out of specification, so blades may not fit on the handles properly.

Class IIModerate

FDASep 26, 2014Nationwide• Teleflex Medical

Black Mamba Suture Passer (Biomet) – Needle Friction (2014)

An investigation identified that high level friction may exist between the needle and Mamba suture passer instrument, causing the needle to break during use.

Class IIModerate

FDASep 26, 2014Nationwide• Biomet, Inc.

Amerigel Daily Dressing Packets (Amerx) – Formulation Deviation (2014)

Formulation deviation

Class IIModerate

FDASep 26, 2014Nationwide• Amerx Health Care Corp.

Bystolic Tablets (Forest) – Dissolution Failure (2014)

Failed Dissolution Specification; at the 6-month stability time point

Class IIModerate

FDASep 26, 2014Nationwide• Forest Pharmaceuticals Inc

Venlafaxine Extended-Release Tablets (Sun Pharma) – Dissolution Issue (2014)

Failed Dissolution Specifications; 12 month stability time point

Class IIModerate

FDASep 26, 2014Nationwide• Sun Pharma Global Inc.

Amerigel Post-op Surgical Kits (Amerx) – Formulation Deviation (2014)

Formulation deviation

Class IIModerate

FDASep 26, 2014Nationwide• Amerx Health Care Corp.

Green Mamba Suture Passer (Biomet) – Needle Friction (2014)

An investigation identified that high level friction may exist between the needle and Mamba suture passer instrument, causing the needle to break during use.

Class IIModerate

FDASep 26, 2014Nationwide• Biomet, Inc.

Maestro Microcatheter (Merit Medical) – Incorrect Tip Size (2014)

These microcatheters were packaged with a 2.8 F distal tip, rather than the labeled 2.4 F.

Class IIModerate

FDASep 26, 2014Nationwide• Merit Medical Systems, Inc.

Calibrator E (Siemens) – Positive Bias (2014)

Positive bias for Calibrator E lot kits ending in 38 and 39 with the ADVIA Centaur Systems Cortisol and Progesterone assays compared to the respective master curves.

Class IIModerate

FDASep 26, 2014Nationwide• Siemens Healthcare Diagnostics, Inc

Dark Chocolate Cherries (Tropical Valley) – Undeclared Peanuts (2014)

Undeclared Nuts

Next by Nature brand Dark Chocolate Cherries Lot 460013 may contain undeclared peanuts (from bulk product).

Class IIModerate

FDASep 26, 2014CA, CO, FL +8 more• Tropical Valley Foods, Inc.

Spirotome Soft-Tissue Biopsy Needle Set (Cook Medical) – Voluntary Recall (2014)

MEDINVENTS, the manufacturer of the Spirotome" Soft-Tissue Biopsy Needle Set distributed by Cook Medical, has initiated a voluntary recall of these products. The recall has been initiated due to customer complaints that the protective caps were dislodged in the pouch. Further investigation disclosed potential dislodging of protective caps on the needle tips on other distributed products.

Class IIModerate

FDASep 26, 2014Nationwide• Cook Medical Incorporated

Biscuit Flaky Layers (Pillsbury) – Undeclared Milk (2014)

Undeclared Milk

Class IIModerate

FDASep 26, 2014CT, IA, ME +6 more• General Mills, Inc.

ACCU-CHEK Spirit Combo Pump (Roche) – Time Setting Failure (2014)

The insulin pump may lose time and date settings during a power interruption (such as a battery change) due to a faulty capacitor. If the capacitor fails, the time and date will return to default setting. Though the pump prompts customers to confirm the time and date, if the user does not recognize the time and date have returned to default, a shift of their basal rate time block could occur.

Class IIModerate

FDASep 25, 2014Nationwide• Roche Diagnostics Operations, Inc.

Equate Moisture Last Solution (Bausch & Lomb) – Disinfectant Specification (2014)

Product lot did not meet the specification for its disinfectants at the time of manufacture.

Class IIModerate

FDASep 25, 2014Nationwide• Bausch & Lomb Inc- Greenville Solutions Plant

COMPASS Linear Accelerator (Iba Dosimetry) – Software Error (2014)

Error in the software. A deviation between reconstructed and planned dose distribution may not be detected prior to treatment and this can result in an over or under-estimation of the pretreatment delivered dose.

Class IIModerate

FDASep 25, 2014IN• Iba Dosimetry Gmbh

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