***REF 66800694***Qty 10***smith&nephew***RENASYS Port Foam Dressing Kit Port***STERILE***Rx Only.***Made in Mexico for/
FDA device recall Z-0875-2012 · posted 2012-01-26 · Terminated
Recall details
- Recalling firm
- Smith & Nephew Inc.
- Reason for recall
- On 12/14/2010, Smith & Nephew, Inc. Wound Management Division in St. Petersburg, FL recalled their RENASYS PORT product code number 66800694 due to small holes in the primary pouch of some of the packaged units of which constituted a breach of the sterile barrier.
- Action taken
- Smith & Nephew, Inc., Wound Management sent an URGENT DEVICE RECALL letter dated December 14, 2010, to all affected customers. The letter identified the product, problem, and actions to be taken. Customers were instructed to immediately identify and isolate the recalled lots in their inventory, complete and fax the response form, and return any affected products to APL Logistics, Inc. in Suwanee, GA. For questions in general, please contact the Customer Care Center at 1-800-876-1261.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- OMP
- Quantity affected
- 71329 units
- Distribution
- Worldwide Distribution - USA (nationwide) including the states of: AZ, CA, GA, MA, MI, MO, MS,.NC, NY,OR, TN, and WI. and the countries of: Australia, Canada, China, England, Germany, Ireland and Sing
- Date initiated
- 2010-12-14
- Date posted
- 2012-01-26
- Date terminated
- 2012-04-30
- Location
- Saint Petersburg, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RENASYS-F NEGATIVE PRESSURE WOUND THERAPY FOAM DRESSING KITS (K082211) | Smith & Nephew, Inc. | 2008-11-14 |