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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker PainPump2, 250 mL PainPump 2.5 inch ExFen catheter and luer lock tubing set

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  Class 2 Device Recall Stryker PainPump2, 250 mL PainPump 2.5 inch ExFen catheter and luer lock tubing set see related information
Date Initiated by Firm June 16, 2009
Date Posted August 19, 2009
Recall Status1 Terminated 3 on October 27, 2010
Recall Number Z-1763-2009
Recall Event ID 52452
510(K)Number K043466  K042405  
Product Classification Pump, infusion - Product Code FRN
Product Stryker PainPump2, 250 mL PainPump with 2.5 inch ExFen catheter and luer lock tubing set, sterile, Stryker Instruments, Kalamazoo, MI; REF 525-156, REF 525-157 and REF 525-158.
Code Information REF 525-156, Lot Numbers: 08113012 through 08365012; REF 525-157, Lots Numbers: 08127012 through 09092012 and REF 525-158, Lot Numbers: 08049012 through 09082012.
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
Action Stryker 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 Commerce 106
Distribution Worldwide 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 Cycle TPLC 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) Database 510(K)s with Product Code = FRN and Original Applicant = STRYKER CORP.
510(K)s with Product Code = FRN and Original Applicant = STRYKER INSTRUMENTS
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