| | Class 2 Recall
Stryker PainPump2 BlockAid |  |
| Date Posted |
January 27, 2009 |
| Recall Number |
Z-0926-2009 |
| Product |
Stryker PainPump 2 Blockaid, 400 mL PainPump for Continuous Nerve Block, sterile, 5 per box. Stryker, Kalamazoo, MI; REF 575-100, Product Number 0575-100-000.
The device is used to deliver controlled amounts of medication and narcotics directly to the intraoperative site for pain management, the pump infuses the medication at an hourly flow rate and provides the option for patient controlled bolus doses. Medications and narcotics are infused through intramuscular, subcutaneous and epidural routs. It is also intended for controlled delivery of local anesthetics and narcotics in close proximity to nerves for postoperative regional anesthesia and pain management, in which case routes of administration may be intraoperative, perineural or percutaneous. |
| Code Information |
Lot Numbers: 08219012, 08220012, 08221012, 08222012, 08225012, 08226012, 08229012, 08231022, 08233012, 08234012, 08235012, 08238022, 08239012, 08241012, 08242012, 08243012, 08246022, 08247012, 08249032, 08250012, 08252022, 08252032, 08253012, 08254012, 08256032, 08256042, 08257012 and 08259022.
|
Recalling Firm/
Manufacturer |
Stryker Instruments Div. of Stryker Corporation
4100 E. Milham Ave.
Portage, Michigan 49002-9704 |
Reason for
Recall |
The pump may display an E-4 error message, which causes the pump to stop dispensing the pain medication.
|
| Action |
Consignees were notified via letter dated 11/12/08 and instructed to locate and destroy the affected lots. Customers were also instructed to complete and return the enclosed Business Reply form via fax (336-499-8603) to Stryker Instruments Regulatory Department. For questions regarding the recalled product, please contact Stryker Instruments at 1-800-800-4236, extension 3808 or extension 4056. |
| Quantity in Commerce |
2,009 boxes |
| Distribution |
Worldwide Distribution including USA and country of Canada. |
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