—#76476

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.

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K043466
Affected lot / code info: 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.

Why it was recalled

The pump may display an E-4 error message, which causes the pump to stop dispensing the pain medication.

Root cause (FDA determination)

Process design

Action the firm took

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.

Recalling firm

Firm: Stryker Instruments Div. of Stryker Corporation
Address: 4100 E. Milham Ave., Portage, Michigan 49002-9704

Distribution

Distribution pattern: Worldwide Distribution including USA and country of Canada.

Timeline

Recall initiated: 2008-11-12
Posted by FDA: 2009-01-27
Terminated: 2009-11-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #76476. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.