Recall Z-2358-2010 ยท MEA Pump, Infusion, Pca
Stryker Instruments Div. of Stryker Corporation
Stryker Sheath 11 gage 8 inch for use with Stryker Pain Pump, REF 540-482, Rx, Sterile, Product of Ireland Manufactured for Stryker Instruments, Kalamazoo, MI.
| Date | Sep 3, 2010 (initiated Feb 1, 2010) |
| Status | Terminated |
| Reason | Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients. |
| Root cause | Process control |
| Action | Stryker Instruments issued an "Urgent Medical Device Recall Notification" letter to consignee risk managers, directors and material managers on February 2, 2010, identifying the affected devices and product issues. The consignees were instructed to: 1) Forward the recall notice and reply form to all affected locations. 2) Review all inventory and quarantine affected product. 3) Destroy all affected product using attached instructions. 4) Complete and return the Business Reply Form to the firm by fax. Stryker Instruments can be contacted at 1-9800-800-4236 ext 4354 |
| Quantity | 18,826 all products |
| Distribution | Nationwide Distribution: United States, including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, and UT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030661 | STRYKER PAINPUMP2 Stryker Instruments, May 30, 2003 |