FDA Device recall Z-1037-2019
Nelaton Urinary Catheter, disposable, sterile, 100 eaches per sales unit
- FDA Device
- Class II
- ongoing
- Published 2019-03-27
On 2019-03-27 the FDA classified a Class II recall of Nelaton Urinary Catheter, disposable, sterile, 100 eaches per sales unit by Convatec, citing an internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1037-2019 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-01-09 |
| Published | 2019-03-27 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Convatec |
| Distribution | US |
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).
Reason
An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
Identifiers
| code_info | Product Codes/REF Numbers: 505599, 505603; Lot Codes: 222348, 222349 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1037-2019%22
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