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Terminated

Stryker ExFen 2.5" extended fenestration catheter set for PainPump, sterile, Stryker Instruments, Kalamazoo, MI; REF 500-25.

FDA Recall Z-1737-2009 · Posted 2009-08-19

Recalling FirmStryker Instruments Div. of Stryker Corporation
Recall StatusTerminated
Product CodeFRN
Date Initiated2009-06-16
Date Terminated2010-10-27
Product Quantity273

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.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K043466PAINPUMP2Stryker Instruments · 2005-05-10K042405PAINPUMP1; PAINPUMP2Stryker Corp. · 2004-10-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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