Recalls / —
—#83074
Product
Stryker PainPump catheter and split introducer needle, sterile, Stryker Instruments, Kalamazoo, MI; REF 500-23.
- 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: 2006040602 through 2009022603.
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 #83074. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.