Recall Z-1781-2009 ยท FRN Pump, Infusion
Stryker Instruments Div. of Stryker Corporation
Stryker PainPump2, 400 mL pre-set PainPump with luer lock tubing set, 5.0 inch ExFen and standard catheter, sterile, Stryker Instruments, Kalamazoo, MI; REF 541-155.
| 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 | 680 |
| 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 |