URI-DRAIN Standard Male External Catheter with Two-Sided Adhesive Strap and Skin Protective Wipe Product ID: 8884732500
FDA device recall Z-2393-2011 · posted 2011-05-27 · Terminated
Recall details
- Recalling firm
- Covidien LP
- Reason for recall
- A component of the Uri-Drain device recalled the Skin-Prep (manufactured by H&P Industries-Triad) a protective wipe due to bacterial contamination
- Action taken
- 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 option 1 (weekdays, 8am to 6:30pm Eastern) and email to: sdfeedback@covidien.com. Should you have any medical questions concerning this recall, please call 508-261-6393.
- Root cause
- Other
- Status
- Terminated
- Product code
- KNX
- Quantity affected
- 52128 units
- Distribution
- Worldwide distribution: USA (nationwide) and countries including: Canada and Bermuda.
- Date initiated
- 2011-04-29
- Date posted
- 2011-05-27
- Date terminated
- 2015-05-29
- Location
- Mansfield, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| URI-DRAIN COMBO KIT FOR MALE INCONTINENC (K770789) | Chesebrough-Pond'S U.S.A. Co. | 1977-10-18 |