Reported Mar 27, 2019 · Ongoing
Nelaton Urinary Catheter, disposable, sterile, 100 eaches per sales unit. Labeled as: CH16/40CM and CH14/40CM Product…
ConvaTec, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ConvaTec, Inc · 7900 Triad Center Dr Ste 400 · Greensboro, NC · 27409-9076
Is this the product you have?
- Nelaton Urinary Catheter, disposable, sterile, 100 eaches per sales unit
- Labeled asCH16/40CM
- and CH14/40CM Product UsageUrinary 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)
- Lot codes and dates
- Product Codes/REF Numbers
505599505603
- Lot Codes
222348222349
- Product Codes/REF Numbers
- Amount recalled
- 5,744,525 units total
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
This product could cause temporary or reversible health problems — stop using it.
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