—#83215

Product

Stryker PainPump, 270 mL infusion kit (2.08 mL/hr), sterile, Stryker Instruments, Kalamazoo, MI; REF 0501-120-000.

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K042405, K043466
Affected lot / code info: Lot Numbers: 2006041001 through 2008100601.

Why it was recalled

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 (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Stryker Instruments Div. of Stryker Corporation
Address: 4100 E. Milham Ave., Kalamazoo, Michigan 49001

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2009-06-16
Posted by FDA: 2009-08-19
Terminated: 2010-10-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #83215. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.