Recall Z-1763-2009 ยท FRN Pump, Infusion
Stryker Instruments Div. of Stryker Corporation
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.
| Date | Aug 19, 2009 (initiated Jun 16, 2009) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 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. |
| FDA record | Open on fda.gov |