Recall Z-2394-2011 ยท KNX Collector, Urine, (And Accessories) For Indwelling Catheter
Covidien LP
URI-DRAIN Male Urinary Control Device - Large Product ID: 8884732598 (sold in Canada only) Intended use:Collector urine from male patients (and accessories) for indwelling catheter
| Date | May 27, 2011 (initiated Apr 29, 2011) |
| Status | Terminated |
| Reason | A component of the Uri-Drain device recalled the Skin-Prep (manufactured by H&P Industries-Triad) a protective wipe due to bacterial contamination |
| Root cause | Other |
| Action | The firm, Covidien, sent an "URGENT PRODUCT RECALL" letter dated April 29, 2011 to its customers via US Postal Service. The letter described the product, problem and actions to be taken. The customers were instructed to immediately stop using the product, place in quarantine, and return any inventory. Distributors are requested to notify their customers. All customers are required to respond to the notice regardless of remaining inventory. Responses will be tracked for follow-up and effectiveness checks. For Customer Service questions regarding the recall please telephone: 1-800-962-9888 op |
| Quantity | 4464 units |
| Distribution | Worldwide distribution: USA (nationwide) and countries including: Canada and Bermuda. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K770789 | URI-DRAIN COMBO KIT FOR MALE INCONTINENC Chesebrough-Pond'S U.S.A. Co., Oct 18, 1977 |