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Showing 4081–4100 of 68218 results

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GE Optima XR240amx (GE Medical) – Column Bolt Issue (2024)

GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement performed, some bolts used in the Column Safety mechanism can be missing. If these bolts are missing and a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work properly causing the arm with X-ray tube and collimator to drop downward on the column track.

FDANov 25, 2024Nationwide• GE Medical Systems, LLC

Crab Cheese Rangoon (Tampa Food) – Undeclared Allergens (2024)

Undeclared Allergen

Undeclared allergens: Milk, Soy, Crustacea Shellfish, Fish

FDANov 25, 2024

FL

• SE Tampa Inc dba Tampa Food

Olanzapine Tablets 2.5mg (Macleods) – Impurity Specifications (2024)

Failed Impurities/Degradation Specifications

Class IIModerate

FDANov 25, 2024Nationwide• Macleods Pharmaceuticals Ltd

Eclipse Mini Holter Recorder (Spacelabs) – Serial Number Error (2024)

Due to a manufacturing error the incorrect device serial number was potentially programmed into the holter recorder. The physical serial number label on the device might not match the serial number programmed into the device.

FDANov 25, 2024AR, CA, CO +19 more• Spacelabs Healthcare, Ltd. Unit B Foxholes Centre; John Tate Road Hertford United Kingdom

Xhibit Telemetry Receiver (Spacelabs) – System Shutdown Risk (2024)

Telemetry receivers with affected software versions may experience unsolicited system shut down and restart (Offline displayed), lasting approximately 1 to 1.5 minutes, which will cause temporary loss of monitoring. If a clinical event occurred during this period, staff may not detect until the system restarts and necessary clinical intervention could be delayed.

FDANov 25, 2024AL, AR, CO +24 more• Spacelabs Healthcare, Inc.

Otological Ventilation Tube (Adept Medical) – Clearance Issue (2024)

Lack of 510(k) clearance.

FDANov 24, 2024Nationwide• Adept Medical Ltd 2-6 Mc Donald Street Morningside, Po Box 10075 Dominion Rd Auckland New Zealand

Biodesign Hiatal Hernia Graft (Cook) – IFU and Expiration (2024)

Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.

FDANov 22, 2024IN, MI• Cook Biotech, Inc.

Clarity Precision Grip Attachments (3M) – Tooth Mating Issue (2024)

Attachments may not mate with the tooth as intended in the digital treatment design.

FDANov 22, 2024Nationwide• 3M Company Health Care Business 3m Center

Biodesign Dural Graft (Cook) – IFU and Expiration (2024)

Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.

FDANov 22, 2024IN, MI• Cook Biotech, Inc.

Biodesign Otologic Butterfly Graft (Cook) – IFU and Expiration (2024)

Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.

FDANov 22, 2024IN, MI• Cook Biotech, Inc.

Citric Complete Concentrate (Nipro) – Mislabeled Concentration (2024)

The outer case is mislabeled as 3.0 K, 2.0 Ca instead of 2.0 K, 3.0 Ca.

FDANov 22, 2024AZ, FL, GA +7 more• Nipro Renal Soultions USA, Corporation

VCF Contraceptive Gel (Apothecus) – Assay Deviation (2024)

CGMP deviations: out of specifications for assay

Class IIModerate

FDANov 22, 2024Nationwide• Apothecus Pharmaceutical Corp.

Dihydroergotamine Mesylate Injection (Provepharm Inc.) – Discoloration (2024)

Discoloration

Class IIModerate

FDANov 22, 2024Nationwide• Provepharm Inc.

Javygtor Tablets 100mg (Dr. Reddy's) – Impurity Specifications (2024)

Failed Impurities/Degradation Specifications

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

Irregular Pigmentation Accelerator (Generitech) – Water System Inconsistency (2024)

CGMP Deviations: Inconsistency in the water systems.

Class IIModerate

FDANov 22, 2024CA• Generitech Corporation

Epoc NXS Host (Siemens) – Software Malfunction (2024)

Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that can result in the incorrect patient name being assigned to a blood measurement by the device if the user of the device does not ensure verification of the correct patient name. The software malfunction has the potential to impact patient safety via misdiagnosis and/or mistreatment by a clinician if the wrong patient information is saved with the test result from the subject device.

FDANov 22, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

Technetium Tc 99m Sulfur Colloid Kit (Jubilant Radiopharma) – Stability Failure (2024)

Failed Stability Specifications

Class IIModerate

FDANov 22, 2024Nationwide• Jubilant Draximage Inc., dba Jubilant Radiopharma

OEC 3D X-Ray System (GE OEC) – Oil Leak Risk (2024)

Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and loss of fluoroscopic imaging capability.

FDANov 21, 2024AK, AZ, CA +41 more• GE OEC Medical Systems, Inc

Medline Procedure Kits (Medline) – Non-Sterile Components (2024)

Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.

FDANov 21, 2024Nationwide• MEDLINE INDUSTRIES, LP Northfield

DocMan Kit (Medline) – Non-Sterile Components (2024)

Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.

FDANov 21, 2024Nationwide• MEDLINE INDUSTRIES, LP Northfield

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