medical Class II Updated 2019-03-27

ConvaTec, Inc recalls Nelaton Urinary Catheter, disposable, sterile, 100 eaches pe

Recalled Product

Nelaton Urinary Catheter, disposable, sterile, 100 eaches per sales unit. Labeled as: CH16/40CM and CH14/40CM Product Usage: Urinary Catheters are sterile disposable devices intended to provide an intermittent pathway for drainage of fluids from the bladder. They are intended to be inserted intermittently through the urethra and up to the bladder enabling urine to drain. They are designed for short-term, intermittent transient use only and are not intended to be left in situ (there is no balloon on the tip to allow the catheter to be retained within the bladder). They are intended for single use only. They are intended to be removed once the bladder is fully drained. The goal of intermittent catheterization using Urology Catheters is to completely empty the bladder and prevent Urinary Tract Infections (UTIs).


Hazard / Issue

An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Product Codes/REF Numbers: 505599, 505603; Lot Codes: 222348, 222349
View official government recall

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