| Class 2 Device Recall Single shot needle | |
Date Initiated by Firm | February 01, 2010 |
Date Posted | September 03, 2010 |
Recall Status1 |
Terminated 3 on March 28, 2011 |
Recall Number | Z-2362-2010 |
Recall Event ID |
54625 |
510(K)Number | K990100 |
Product Classification |
Needle, electrode - Product Code GXZ
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Product | 22G x 50m/20 bevel Single Shot Needle, REF 552-022-050, Rx, Sterile, Distributed by: Stryker Instruments, Kalamazoo, MI. |
Code Information |
20130217, 20140414, 20140507, 20140527, 20140528, 20140610, 20140716, 5046231300, 5101251562, 5122261791, 5133266600, 5153274678, 5157276042, 5187287783, 5200294494, 5208298022, 5241310863, 5269320112, 5283325624, 5291331195, 5306337318, 5319341187, 5332345743, 5342350291, 6004356829, 6004360560, 6037374453, 6054381257, 6061387795, 6073391292, 6088396287, 6090400765, 6107408674, 6121415236, 6135420667, 6150423848, 6158429977, 6163432688, 6172437498, 6174438863, 6186443028, 6221458770, 6255473157, 6283486655, 6313500842, 6321504503, 6342514077, 6353518040, 7005525171, 7026536490, 7037541403, 7054549741, 7068555927, 7074559182, 7107573680, 7142589688, 7176604912, 7184608177, 7192611054, 7263643184, 7290656233, 7330674022, 7330674024, 7355686009, 8022698982, 8039708180 8045710627, 8052714216, 8070721966, 8105737996, 8148758188, 8150759732, 8176772079, 8191778150, 8226795127, 8277818561, 8302830726, 9009870015 and 9029881744. |
Recalling Firm/ Manufacturer |
Stryker Instruments Div. of Stryker Corporation 4100 E. Milham Ave. Kalamazoo MI 49001
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For Additional Information Contact | Angela Regainis 269-323-7700 |
Manufacturer 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 2 | 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 in Commerce | 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = GXZ
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