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FDA (Device enforcement)Recalled 2022-11-01class ii

Cardinal Health: Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 1000 mL Drainage Bag Product Code: 3450LF Intended for urinary drainage from the bladd

Hazard

Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropriate time, this may increase the risk of urinary retention

Details from the source

Reason for recall: Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropriate time, this may increase the risk of urinary retention Distribution: Nationwide Quantity: N/A Lot/code info: UDI-DI: Each 10884521009585 Case 20884521009582 Lot Numbers: 2216806064, 2214452064, 2212401164 2210219764, 2209525364, 2208816464 2206737964, 2206727564

UPC codes

10884521009585, 20884521009582

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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