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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker 5.0 catheter set for PainPump2 and AutoFuser PainPump

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 Class 2 Device Recall Stryker 5.0 catheter set for PainPump2 and AutoFuser PainPumpsee related information
Date Initiated by FirmJune 16, 2009
Date PostedAugust 19, 2009
Recall Status1 Terminated 3 on October 27, 2010
Recall NumberZ-1772-2009
Recall Event ID 52452
510(K)NumberK042405 K043466 
Product Classification Pump, infusion - Product Code FRN
ProductStryker 5.0 catheter set for PainPump2 and AutoFuser PainPump, sterile, Stryker Instruments, Kalamazoo, MI; REF 0537-005-000.
Code Information Lot Numbers: 8136753340 through 9131936639.
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		The catheter may break when removed from the body, or the catheter may have kinks or be occluded such that the patient will not receive the intended quantity of medication.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionStryker Instruments issued a recall letter dated June 16, 2009 and instructed Consignees to cease using and destroy the product and to return a business reply form for credit via fax to Stryker Instruments Regulatory Department, 1-866-521-2762. For further questions, contact Stryker Instruments at 1-800-800-4236 extension 3808.
Quantity in Commerce89
DistributionWorldwide Distribution -- Including the United States, Argentina, Australia, Brazil, Canada, England, France, Germany, Hong Kong, Italy, Japan, Latin America, Malaysia, Mexico, Netherlands, New Zealand, Singapore, South Africa, Spain, Sweden, Switzerland and Taiwan.
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 = FRN
510(K)s with Product Code = FRN
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