Recall Z-1037-2019 ยท KOD Catheter, Urological
ConvaTec, Inc
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 sho
| Date | Jan 9, 2019 |
| Status | Open, Classified |
| Reason | An internal assessment of packaging confirmed the potential for a breach in the sterile barrier. |
| Root cause | Package design/selection |
| Action | ConvaTec notified customers on about 01/09/2019 via "URGENT: VOLUNTARY MEDICAL DEVICE RECALL" letter. Instructions included how to identify affected product on the primary packaging and/or shipping carton as well as specific instructions for distributors, retailers, and end users (hospitals, EMT services, others). Distributors were instructed to inspect their inventory for affected products, perform a count of affected product in inventory, complete and return the response form, contact Customer Service at 1-800-582-6514 or ushcreturns@ups.com to report affected inventory on hand, forward |
| Quantity | 5,744,525 units total |
| Distribution | 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, K |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K896729 | NELATON-, FEMALE - OR TIEMANN CATHETER Unoplast A/S, Nov 5, 1990 |