| Class 2 Device Recall Stryker PainPump ExFen, 5.0 in. antimicrobial silver ExFen catheter kit | |
Date Initiated by Firm | June 16, 2009 |
Date Posted | August 19, 2009 |
Recall Status1 |
Terminated 3 on October 27, 2010 |
Recall Number | Z-1784-2009 |
Recall Event ID |
52452 |
510(K)Number | K042405 K043466 |
Product Classification |
Pump, infusion - Product Code FRN
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Product | Stryker PainPump ExFen, 5.0 in. antimicrobial silver ExFen catheter kit, sterile, Stryker Instruments, Kalamazoo, MI; REF 0555-005-000. |
Code Information |
LotNumbers: 2008052702 through 2008062502. |
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 | 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 | 222 |
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 |
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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 = FRN 510(K)s with Product Code = FRN
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