Recall Z-2367-2010
Stryker Instruments Div. of Stryker Corporation · initiated February 1, 2010
Product
18G x 90mm/20 Tuohy Catheter Kit, REF 553-118-090, Rx, Sterile, Distributed by: Stryker Instruments, Kalamazoo, MI.
Codes / lots: 0887730428, 20130205, 20130421, 20130422, 5125262586, 5146272236, 5167280672, 5187287778, 5201294495, 5223302036, 5259318014, 5283325623, 5305337322, 5308337696, 5336344652, 6018365172, 6034385141, 6073391289, 6090400762, 6107408673, 6124416925, 6152427564, 6171434889, 6173438179, 6181440288, 6187443412, 6200449170, 6227460910, 6268479135, 6286486661, 6342514078, 7012528660, 7044544767, 7059551766, 7065554362, 7088565465, 7107573688, 7134586531, 7165600825, 7197613217, 7261642324, 7262643186, 7289656229, 7316668203, 7337676790, 7338677399, 7348682596, 8008691271, 8022698985, 8056715161, 8070721969, 8121746168, 8203783647, 8277818562 and 8302830743.
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.
FDA-determined 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
Details
- Recall number
- Z-2367-2010
- Initiated
- February 1, 2010
- Posted by FDA
- September 3, 2010
- Terminated
- March 28, 2011
- Product code
- GXZ – Electrode, Needle
- 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.
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation, Kalamazoo, MI
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2356-2010 | Stryker Pain Pump 2 Luer Cap, REF 525-401, Rx, Sterile, Product of Ireland Manufactured…Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective… | 02/01/2010Terminated |
| Z-2357-2010 | Stryker Sheath 17 gage 12 inch for use with Stryker Pain Pump, REF 540-428, Rx, Sterile…Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective… | 02/01/2010Terminated |
| Z-2358-2010 | Stryker Sheath 11 gage 8 inch for use with Stryker Pain Pump, REF 540-482, Rx, Sterile…Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective… | 02/01/2010Terminated |
| Z-2359-2010 | Stryker Sheath 11 gage 8 inch for use with Stryker Pain Pump, REF 540-482, Rx, Sterile…Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective… | 02/01/2010Terminated |
| Z-2360-2010 | Poly Stim II Nerve Stimulator 8 inch for use with Stryker Pain Pump, REF 550-100, Rx…Device may malfunction and lead to ineffective stimulation, which could delay finding the nerve and the… | 02/01/2010Terminated |
| Z-2361-2010 | 21G x 90mm/20 Bevel Single Shot Needle, REF 55-021-090, Rx, Sterile, Distributed by:…Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective… | 02/01/2010Terminated |
| Z-2362-2010 | 22G x 50m/20 bevel Single Shot Needle, REF 552-022-050, Rx, Sterile, Distributed by:…Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective… | 02/01/2010Terminated |
| Z-2363-2010 | 21G x 150m/20 bevel Single Shot Needle, REF 552-021-150, Rx, Sterile, Distributed by:…Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective… | 02/01/2010Terminated |
| Z-2364-2010 | 22G x 70mm/20 bevel Single Shot Needle, REF 552-022-70, Rx, Sterile, Distributed by:…Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective… | 02/01/2010Terminated |
| Z-2365-2010 | 24G x 25mm/20 bevel Single Shot Needle, REF 552-024-025, Rx, Sterile, Distributed by:…Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective… | 02/01/2010Terminated |
| Z-2366-2010 | 18G x 50mm/20 Tuohy Catheter Kit, REF 553-118-050, Rx, Sterile, Distributed by: Stryker…Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective… | 02/01/2010Terminated |
| Z-2368-2010 | 18G x 150m Tuohy Catheter Kit, REF 553-118-150, Rx, Sterile, Distributed by: Stryker…Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective… | 02/01/2010Terminated |
| Z-2369-2010 | 17G x 50m Tuohy Catheter Kit, REF 553-218-50, Rx, Sterile, Distributed by: Stryker…Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective… | 02/01/2010Terminated |
| Z-2370-2010 | 17G x 90m Tuohy Stimulation Catheter Kit, REF 553-218-90, Rx, Sterile, Distributed by:…Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective… | 02/01/2010Terminated |
| Z-2371-2010 | 17G x 150mm Tuohy Stimulation Catheter Kit, REF 553-218-150, Rx, Sterile, Distributed…Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective… | 02/01/2010Terminated |
| Z-2372-2010 | 17G x 150mm Stimulation Catheter Continuous Nerve Block Tray, REF 553-318-050, Rx…Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective… | 02/01/2010Terminated |
| Z-2373-2010 | 17G x 90mm Stimulation Catheter Continuous Nerve Block Tray, REF 553-318-090, Rx…Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective… | 02/01/2010Terminated |
| Z-2374-2010 | 17G x 150mm Stimulation Catheter Continuous Nerve Block Tray, REF 553-318-150, Rx…Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective… | 02/01/2010Terminated |
| Z-2375-2010 | 21G x 90mm/45 Bevel Single Shot Needle, REF 554-021-090, Rx, Sterile, Distributed by:…Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective… | 02/01/2010Terminated |
| Z-2376-2010 | 21G x 150mm Stimulation Catheter Continuous Nerve Block Tray, REF 554-021-150, Rx…Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective… | 02/01/2010Terminated |
| Z-2377-2010 | 22G x 50mm/45 Bevel Single Shot Needle, REF 554-022-050, Rx, Sterile, Distributed by:…Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective… | 02/01/2010Terminated |
| Z-2378-2010 | 22G x 70mm/45 Bevel Single Shot Needle, REF 554-022-070, Rx, Sterile, Distributed by:…Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective… | 02/01/2010Terminated |
| Z-2379-2010 | 24G x 25mm/45 Bevel Single Shot Needle, REF 554-024-025, Rx, Sterile, Distributed by:…Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective… | 02/01/2010Terminated |