Date Initiated by Firm | May 14, 2009 |
Date Posted | September 04, 2009 |
Recall Status1 |
Terminated 3 on January 20, 2010 |
Recall Number | Z-1853-2009 |
Recall Event ID |
52163 |
510(K)Number | K041585 K060258 |
Product Classification |
Infusion pump for pain medication. - Product Code MEB
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Product | Stryker 550 mL AutoFuser PainPump, dual site continuous, 4 mL/hr, 2 x 10.0 in. catheters, sterile, REF 0535-400-210. |
Code Information |
Lots 08142756254 through 09125933719. |
Recalling Firm/ Manufacturer |
Stryker Instruments Div. of Stryker Corporation 4100 E. Milham Ave. Kalamazoo MI 49001
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For Additional Information Contact | 800-800-4236 Ext. 3808 |
Manufacturer Reason for Recall | Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation. |
FDA Determined Cause 2 | Process control |
Action | Stryker sent all consignees a Medical Device Recall Notification letter dated 5/14/09 and instructed to locate and destroy the recalled products and to complete and return the business reply card. |
Quantity in Commerce | 28,755 of all pumps |
Distribution | Nationwide and Canada. |
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 = MEB 510(K)s with Product Code = MEB
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