—#83228

Product

Stryker PainPump2, 250 mL PainPump with 2.5 inch ExFen catheter and luer lock tubing set, sterile, Stryker Instruments, Kalamazoo, MI; REF 525-156, REF 525-157 and REF 525-158.

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K042405, K043466
Affected lot / code info: REF 525-156, Lot Numbers: 08113012 through 08365012; REF 525-157, Lots Numbers: 08127012 through 09092012 and REF 525-158, Lot Numbers: 08049012 through 09082012.

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 #83228. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.