Nelaton Urinary Catheter — Class II medical device recall Z-1037-2019
Ongoing recall by ConvaTec, Inc, reported 2019-03-27, distributed nationwide. An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
| Recall number | Z-1037-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ConvaTec, Inc, Greensboro, NC, United States |
| Recall initiated | 2019-01-09 |
| Classified | 2019-03-21 |
| Reported by FDA | 2019-03-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, CA, CH, CZ, DE, DK, DZ, EE, EG, ES, FI, FR, GB, GR, HK, HR, HU, IL, IS, IT, KE, KR, KW, LB, NL, NO, NZ, PL, QA, SE, SG, SK, TR, VN, ZA |
| Quantity | 5,744,525 units |
| Reason classes | sterility |
| Lot numbers | 222348, 222349 |
| Model numbers | 505599, 505603 |
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 for recall
An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1037-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.