Stryker ExFen 5.0" extended fenestration catheter set for PainPump, sterile, Stryker Instruments, Kalamazoo, MI; REF 500
FDA device recall Z-1738-2009 · posted 2009-08-19 · Terminated
Recall details
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 290
- Distribution
- Worldwide Distribution -- Including the United States, Argentina, Australia, Brazil, Canada, England, France, Germany, Hong Kong, Italy, Japan, Latin America, Malaysia, Mexico, Netherlands, New Zealan
- Date initiated
- 2009-06-16
- Date posted
- 2009-08-19
- Date terminated
- 2010-10-27
- Location
- Kalamazoo, MI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PAINPUMP2 (K043466) | Stryker Instruments | 2005-05-10 |
| PAINPUMP1; PAINPUMP2 (K042405) | Stryker Corp. | 2004-10-14 |