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Showing 9261–9280 of 11714 results

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15 Liters Drain Bag (Baxter) – regulatory clearance issue (2022)

Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.

FDAApr 21, 2022Nationwide• Baxter Healthcare Corporation

Effluent Sample Bag (Baxter) – regulatory clearance issue (2022)

Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.

FDAApr 21, 2022Nationwide• Baxter Healthcare Corporation

Medline Enzymatic Cleaning Sponge (Medline) – microbial contamination (2022)

Sporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has been identified as microbial contamination.

FDAApr 21, 2022Nationwide• MEDLINE INDUSTRIES, LP Northfield

Medline Bedside Cleaning Kit (Medline) – microbial contamination (2022)

Sporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has been identified as microbial contamination.

FDAApr 21, 2022Nationwide• MEDLINE INDUSTRIES, LP Northfield

APD Drain Manifold (Baxter) – regulatory clearance issue (2022)

Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.

FDAApr 21, 2022Nationwide• Baxter Healthcare Corporation

Extension Set (Baxter) – regulatory clearance issue (2022)

Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.

FDAApr 21, 2022Nationwide• Baxter Healthcare Corporation

Atrium Thoracic Catheter (Atrium) – expiration date mismatch (2022)

Mismatch between the expiration date on the sterile barrier pouch and the expiration date on the case/shipper label. Product sterile barrier pouch label expiration date of 16SEP2024 (2024-09-16) while the case and shipper labels both showed 21SEP2024 (2024-09-21), causing product being used for up to five (5) days past the true expiration date

FDAApr 21, 2022AZ, IL, KS +7 more• Atrium Medical Corporation

Erythromycin Topical Gel (McKesson) – Stability Study Discontinued (2022)

CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.

Class IIModerate

FDAApr 21, 2022Nationwide• McKesson Corporation dba McKesson Drug Company

Lidocaine Hydrochloride Solution (McKesson) – Stability Study Discontinued (2022)

CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.

Class IIModerate

FDAApr 21, 2022Nationwide• McKesson Corporation dba McKesson Drug Company

Halobetasol Propionate Ointment (McKesson) – Stability Study Discontinued (2022)

CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.

Class IIModerate

FDAApr 21, 2022Nationwide• McKesson Corporation dba McKesson Drug Company

Lidocaine Prilocaine Cream (McKesson) – Stability Study Discontinued (2022)

CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.

Class IIModerate

FDAApr 21, 2022Nationwide• McKesson Corporation dba McKesson Drug Company

Betamethasone Dipropionate Ointment (McKesson) – Stability Study Discontinued (2022)

CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.

Class IIModerate

FDAApr 21, 2022Nationwide• McKesson Corporation dba McKesson Drug Company

Medline Foam Bedside Kit (Medline) – microbial contamination (2022)

Sporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has been identified as microbial contamination.

FDAApr 21, 2022Nationwide• MEDLINE INDUSTRIES, LP Northfield

C304-HIS Device (Medtronic) – sterility barrier concern (2022)

The firm's internal processes identified that certain lots may have an improperly sealed barrier that could potentially compromise sterility.

FDAApr 20, 2022Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Proteus235 Proton Therapy (Ion Beam) – scanning magnet issue (2022)

First layer of Uniform Scanning treatment fields is sometimes irradiated with incorrect Scanning Magnet setpoints resulting in the field size may be smaller than expected and the irradiated area may receive more dose than prescribed

FDAApr 20, 2022Nationwide• Ion Beam Applications S.A. 3 Chemin Du Cyclotron Louvain-la-neuve Belgium

Cardioblate Gemini-s (Medtronic) – jaw tip fracture (2022)

Firm detected an increase in complaints related to fractured jaw tips of the Cardioblate Gemini-s.

FDAApr 20, 2022Nationwide• Medtronic Perfusion Systems

Uretero-Reno Fiberscope (Olympus) – adhesive problem (2022)

Incorrect adhesive used to secure the diopter ring and nameplate ring. Improperly connected diopter ring may result in the loss of adjustment function leading to a blurred field of vision and unintentional contact with the patients body and in rare cases perforation in the urinary tract/renal pelvis.

FDAApr 20, 2022CA, FL, MD +6 more• Olympus Corporation of the Americas

Olympus Cystonephrofiberscope (Olympus) – adhesive problem (2022)

Incorrect adhesive used to secure the diopter ring and nameplate ring. Improperly connected diopter ring may result in the loss of adjustment function leading to a blurred field of vision and unintentional contact with the patients body and in rare cases perforation in the urinary tract/renal pelvis.

FDAApr 20, 2022CA, FL, MD +6 more• Olympus Corporation of the Americas

GE Ventilator Batteries (GE Healthcare) – backup power issue (2022)

Insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply.

FDAApr 18, 2022Nationwide• GE Healthcare, LLC

Medfusion Syringe Pump (Smiths Medical) – multiple issues (2022)

Multiple issues with the potential for interruption of therapy or over-infusion: 1. Primary Audible Alarm (PAA), 2. Unanticipated Depleted Battery Alarms, 3. Time Base Alarm, 4. Intermittent Volume Over Time (IVOT) - Infusion Continues after System Failure, 5. Clearing of Program Volume Delivered (PVD), 6. False Alarm for Rate Below Recommended Minimum for Syringe Size, 7. Incorrect Bolus or Loading Dose Time Display, 8. Domain Name Server (DNS) Port 1001

FDAApr 18, 2022Nationwide• Smiths Medical ASD Inc.

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