Y-Type Blood/Solution Set, catalog #1C8117; Standard Blood Filter (170 to 260 micron), Drip Chamber Pump, Injection Site
FDA device recall Z-0449-03 · posted 2003-01-16 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Corp.
- Reason for recall
- Leakage may occur at the inlet port
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- KSB
- Quantity affected
- 3,792 sets
- Distribution
- Nationwide
- Date initiated
- 2002-12-18
- Date posted
- 2003-01-16
- Date terminated
- 2003-09-30
- Location
- Round Lake, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BLOOD/SOLUTION SET W/PRESSURE PUMP (K881321) | Baxter Healthcare Corp | 1988-06-16 |