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.
This recall has been terminated (originally issued September 3, 2010).
- Recall Initiated
- February 1, 2010
- Posted
- September 3, 2010
- Terminated
- March 28, 2011
- Recall Number
- Z-2358-2010
- Quantity
- 18,826 all products
- Firm Location
- Kalamazoo, MI
- Official Source
- View on FDA website ↗
Reason for Recall
Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.
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.
Lot / Code Info
2009042103.
Root Cause
Process control
Action Taken
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