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Safe-t-Centesis Catheter (Bard) – needle size mismatch (2022)

There is the potential that a 6 Fr Catheter Drainage kit contains an 8 Fr needle instead of a 6 Fr needle. They can be used in conjunction with the following drainage methods: Universal extension set and drainage bag, vacuum bottle, and wall suction.

FDAApr 22, 2022Nationwide• Bard Peripheral Vascular Inc

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

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Safe-t-Centesis Catheter (Bard) – needle size mismatch (2022)

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

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

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

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

5 Prong Manifold Set (Baxter) – regulatory clearance issue (2022)

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

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

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

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

Locking Cap (Baxter) – regulatory clearance issue (2022)

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

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

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

Olympus Cystonephrofiberscope (Olympus) – adhesive problem (2022)

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

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

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

Medfusion Syringe Pump (Smiths Medical) – Therapy Interruption (2022)

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