Recall Z-0875-2012 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
Smith & Nephew Inc.
***REF 66800694***Qty 10***smith&nephew***RENASYS Port Foam Dressing Kit Port***STERILE***Rx Only.***Made in Mexico for/Fabrique au Mexique pour: Smith & Nephew, Inc., St. Petersburg, FL 33716***Smith & Nephew Medical Limited Hull HU3 2BN England***Lot 123456. Product Usage: The product is a suction device used as an accessory to the foam dressing kits, which is used in conjunction with Smith &
| Date | Jan 26, 2012 (initiated Dec 14, 2010) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 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 Singapore. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082211 | RENASYS-F NEGATIVE PRESSURE WOUND THERAPY FOAM DRESSING KITS Smith & Nephew, Inc., Nov 14, 2008 |