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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker 100 mL AutoFuser PainPump

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 Class 2 Device Recall Stryker 100 mL AutoFuser PainPumpsee related information
Date Initiated by FirmMay 14, 2009
Date PostedSeptember 04, 2009
Recall Status1 Terminated 3 on January 20, 2010
Recall NumberZ-1868-2009
Recall Event ID 52163
510(K)NumberK041585 K060258 
Product Classification Infusion pump for pain medication. - Product Code MEB
ProductStryker 100 mL AutoFuser PainPump, single site continuous, 2 mL/hr with 2.5 in. antimicrobial silver ExFen catheter, sterile, REF 8531-200-025.
Code Information Lot 09111920718.
Recalling Firm/
Manufacturer
Stryker Instruments Div. of Stryker Corporation
4100 E. Milham Ave.
Kalamazoo MI 49001
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
ActionStryker 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 Commerce28,755 of all pumps
DistributionNationwide and Canada.
Total Product Life CycleTPLC Device Report

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.
510(K) Database510(K)s with Product Code = MEB
510(K)s with Product Code = MEB
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