Stryker dual 2.5 catheter set for PainPump2 and AutoFuser PainPump, sterile, Stryker Instruments, Kalamazoo, MI; REF 0537-225-000.
FDA Recall Z-1777-2009 · Posted 2009-08-19
Recalling FirmStryker Instruments Div. of Stryker Corporation
Recall StatusTerminated
Product CodeFRN
Date Initiated2009-06-16
Date Terminated2010-10-27
Product Quantity29
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.