Baxter Interlink System Microbore T-Connector Extension Set with 0.22 Micron High Pressure Pediatric Filter, catalog 2N3
FDA device recall Z-0517-03 · posted 2003-02-06 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Corp.
- Reason for recall
- The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
- Action taken
- Recalled by letter dated 10/17/02. Accounts were informed of the potential for the filters to be 1.2 micron filters instead of the 0.22. micron filters as labeled. The accounts were requested to examine their inventories for the affected catalog numbers and destroy the units found for credit.
- Root cause
- Other
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 47,000 units
- Distribution
- Nationwide, Australia, Puerto Rico, Brazil, Canada, Sweden, New Zealand, Japan, Mexico, American Samoa, El Salvador, Turkey, Saudi Arabia, Austria, Cayman Islands, Macedonia, Honduras, Kuwait, Hong Ko
- Date initiated
- 2002-10-17
- Date posted
- 2003-02-06
- Date terminated
- 2004-02-04
- Location
- Round Lake, IL
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INTERLINK(TM) INJECTION SITE (K925126) | Baxter Healthcare Corp | 1993-06-18 |
| INTERLINK SYSTEM - T-CONNECTOR EXTENSION SET (K921899) | Baxter Healthcare Corp | 1993-04-20 |
| LOW PLASTICIZER ADMINISTRATION SETS (K791496) | Travenol Laboratories, S.A. | 1980-04-08 |