—#74922

Product

Stryker PainPump, Two Site Infusion Kit with ExFen 2.5", 120 mL Infusion Kit, sterile, 5 per box. Manufactured for Stryker Instruments, Kalamazoo, MI. Product Number 0500-166-025, REF 500-166-25. A disposable syringe infuser which uses sustained vacuum pressure to deliver a continuous infusion of medications or fluids at a controlled rate. It delivers controlled amounts of medication directly to the intraoperative site for pain management and/or antibiotic administration. It is also intended for controlled delivery of local anesthetics in close proximity to nerves for postoperative regional anesthesia and pain management. 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: K042405
Affected lot / code info: Lot Number: 2008011403, 2008020502, 2008061701 and 2008072102.

Why it was recalled

There is a potential for the pump to overinfuse.

Root cause (FDA determination)

Process control

Action the firm took

A "Medical Device Recall Notification" letter dated November 11, 2008 was issued to consignees. The letter identified the problem and instructed consignees to locate and destroy all affected products. Customers were also instructed to complete the enclosed Business Reply form and fax it to Stryker Instruments Regulatory Department at 866-521-2760. For questions regarding the recalled product, contact Stryker Instruments at 1-800-800-4236, extension 4056 or extension 3808.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution.

Timeline

Recall initiated: 2008-11-07
Posted by FDA: 2009-02-02
Terminated: 2009-12-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #74922. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.