21G x 90mm/45 Bevel Single Shot Needle, REF 554-021-090, Rx, Sterile, Distributed by: Stryker Instruments, Kalamazoo, MI.
FDA Recall Z-2375-2010 · Posted 2010-09-03
Recalling FirmStryker Instruments Div. of Stryker Corporation
Recall StatusTerminated
Product CodeGXZ
Date Initiated2010-02-01
Date Terminated2011-03-28
Product Quantity18,826 all products.
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.
Firm 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
Root Cause
Process control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.