Device 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).
Z-1037-2019
Product summary
- Firm
- ConvaTec, Inc
- Event
- Event 82039
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5,744,525 units total
- Official record key
device-enforcement:Z-1037-2019
Official wording
Reason: An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
Code information: Product Codes/REF Numbers: 505599, 505603; Lot Codes: 222348, 222349
Distribution pattern: Worldwide Distribution - US Nationwide in the states of IL, MI, PA, WI. and the countries of Algeria, Australia, Austria, Belgium, Canada, Croatia, Czechia, Czech Republic, Denmark, Egypt, Estonia, Finland, Faroe Islands, France, Germany, Greece, Hong Kong, Hungary, Iceland, Israel, Italy, Kenya, Korea, Kuwait, Lebanon, Myanmar, Netherlands, New Zealand, Norway, Poland, Qatar, Singapore, Spain, Slovakia, South Africa, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, United States, Vietnam.
Derived failure modes
-
Sterility assurance
breach in the sterile barrier