Recalls / —
—#25453
Product
Y-Type Blood/Solution Set, catalog #1C8372; Standard Blood Filter (170 to 260 micron), Drip Chamber Pump, 2 Injection Sites, Male Luer Lock Adapter, 111'' long, 10 drops per mL; Baxter Healthcare Corporation, Deerfield, IL 60015
- FDA product code
- KSB — Set, Transfer (Blood/Plasma)
- Device class
- Class 2
- Medical specialty
- Hematology
- 510(k) numbers
- K925126
- Affected lot / code info
- lots GR183152, GR183483, GR184622, GR185652
Why it was recalled
Leakage may occur at the inlet port
Root cause (FDA determination)
Other
Action the firm took
The affected product codes and lot numbers were recalled by letter dated 12/18/02. The customers were informed of the potential leakage at the inlet port, and were requested to inspect their inventory for the affected products and destroy those found. The accounts were requested to complete the enclosed reply form and certificate of destruction and return them to Baxter for credit issuance.
Recalling firm
- Firm
- Baxter Healthcare Corp. Rt
- Address
- 120 & Wilson Rd, Round Lake, Illinois 60073
Distribution
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2002-12-18
- Posted by FDA
- 2003-01-16
- Terminated
- 2003-09-30
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #25453. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.