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Showing 3561–3580 of 11714 results

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Lanthanum Carbonate Tablets (Cipla) – Broken Tablets (2024)

Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.

Class IIModerate

FDAOct 23, 2024Nationwide• Cipla USA, Inc.

Lanthanum Carbonate Tablets (Cipla) – Broken Tablets (2024)

Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.

Class IIModerate

FDAOct 23, 2024Nationwide• Cipla USA, Inc.

Counterfeit Batteries (ICU Medical) – Battery Authenticity (2024)

ICU Medical has received reports of allegedly counterfeit CSB batteries being used with Plum Infusion Systems. While these non-OEM batteries are visually similar to the Plum batteries supplied by ICU Medical, they are in fact not the same batteries and have not been tested or validated for use with Plum Infusion Systems. Preliminary reports suggest that these non-OEM batteries fail to hold their charge and the pump may display messages to replace batteries earlier than expected. OSI Batteries and their customers are distributing these non-OEM CSB batteries without authorization from ICU Medical.

FDAOct 22, 2024Nationwide• ICU Medical, Inc.

Ivalon Eye Wick 20cm (Carwild) – Package Seal Issue (2024)

Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product.

FDAOct 22, 2024AL, FL, IL +2 more• Carwild Corporation

Ivalon Nasal Packing (Carwild) – Package Seal Issue (2024)

Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product.

FDAOct 22, 2024AL, FL, IL +2 more• Carwild Corporation

Morphine Sulfate Tablets 30mg (Dr. Reddy's) – Impurity Spec Failure (2024)

Failed Impurities/Degradation Specification

Class IIModerate

FDAOct 22, 2024Nationwide• Dr. Reddy's Laboratories, Inc.

Morphine Sulfate Tablets 15mg (Dr. Reddy's) – Impurity Spec Failure (2024)

Failed Impurities/Degradation Specification

Class IIModerate

FDAOct 22, 2024Nationwide• Dr. Reddy's Laboratories, Inc.

Kirkland Signature Smoked Salmon (Acme Smoked Fish) - Listeria Risk (2024)

Listeria

The firm was notified after laboratory analysis that the product test positive for Listeria monocytogenes.

Class IHigh

FDAOct 22, 2024FL, IN• Acme Smoked Fish Corp.

Ivalon Surgical Spear (Carwild) – Package Seal Issue (2024)

Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product.

FDAOct 22, 2024AL, FL, IL +2 more• Carwild Corporation

MICRO-X Rover Mobile X-ray System (Micro-X) – Operation Requirements (2024)

Mobile x-ray system receiving/storage(operation) requirements to be followed: Temp:14 to 131(50 to 86) degrees F, RH:10% to 86%(30% to 60%) allow condensation dry time, Atmospheric Pressure:50kPa to 106 kPa(70kPa to 106kPa), Altitude:-102ft to 12,000 ft, (Maximum Gradient:9 degrees Fahrenheit), which mitigate risk of capacitor malfunction, unpredictable behavior, overheating, unintended start-up.

FDAOct 22, 2024CA, MD, TX +1 more• Micro-X Ltd. Unit 14 6 Mab Eastern Promenade Tonsley Australia

JuggerLoc Drill Guide (Biomet) – Packaging Deformation (2024)

Firm received complaints reporting that guides were warped when pulled out of packaging. This issue may result in extension of surgery to find another product, or may lead to adverse local tissue reaction leading to surgical intervention.

FDAOct 21, 2024Nationwide• Biomet, Inc.

Medline Iris Scissors (Medline) – Tip Protector Failure (2024)

Tip protector may fall off within the packaging, resulting in compromised sterile barrier system and loss of sterility.

FDAOct 21, 2024Nationwide• MEDLINE INDUSTRIES, LP Northfield

Karl Storz Irrigation Tubing (Karl Storz) – Labeling Error (2024)

Due to improper labeling of products. An intended use on the label has not been reviewed and approved by FDA for distribution in the U.S.

FDAOct 21, 2024Nationwide• Karl Storz Endoscopy

Siemens Atellica Cuvette Segment (Siemens) – Manufacturing Defect (2024)

A manufacturing defect causes Atellica CH Reaction Ring Cuvette Segments with lot numbers N15 on the packaging or 15 on the underside of the cuvette segment have a potential for imprecision and erroneously depressed or elevated QC and patient results for seven (7) analytes: Ammonia, Acetaminophen, Alanine Aminotransferase (ALT), Hemoglobin A1c, Creatinine Kinase (CK), Cystatin C, and Salicylate.

FDAOct 21, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

Baxter MiniCap PD Transfer Set (Baxter) – Chemical Risk (2024)

Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.

FDAOct 21, 2024Nationwide• Baxter Healthcare Corporation

Atellica B2M Test (Siemens) – Result Accuracy Issue (2024)

Potential for falsely depressed auto-diluted results for samples above the measuring interval of 18.00 mg/L, up to 30.00 mg/L, when using the Atellica CH 2-Microglobulin (B2M) reagent.

FDAOct 21, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

Z-800 Infusion System (Zyno Medical) – Battery Discharge (2024)

Potential for the battery to deplete over time from self-discharge and internal parasitic leakage current despite being continuously plugged into AC mains.

FDAOct 18, 2024Nationwide• Zyno Medical LLC

Biofill Infiltration Cannula (Human Med) – Water Jet Deviation (2024)

The cannula tubes do not comply with the specification. The water jet emerging from the nozzle of the nonconforming cannulas may emerge as a spot jet rather than a fan-shaped spray jet.

FDAOct 18, 2024Nationwide• HUMAN MED AG Wilhelm-Hennemann-Str. 9 Schwerin Germany

Essenz HLM (LivaNova) – Touchscreen Interruption (2024)

Heart-Lung Machine GUI touchscreen may go dark for 10-15 seconds, safety/performance functions remain operational before reset, control maintained through backup control panel, but second reset may occur, may lead to gas blender standby, then gas blender must be reactivated using user interface on blender, sensors deactivated until new case started; GUI reset can lead to Hypoxia and Hypoperfusion.

FDAOct 18, 2024Nationwide• LivaNova Deutschland GmbH Lindberghstr. 25 Munich Germany

Sunitinib Capsules 12.5mg (AvKARE) – Label Mix-Up (2024)

Labeling: Label Mix-Up

Class IIModerate

FDAOct 18, 2024Nationwide• AvKARE

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