Baxter Auto Syringe Micro-Volume Extension Set with 0.22 Micron Filter, catalog 1M8522 and 1M8522Y; Baxter Healthcare Co
FDA device recall Z-0512-03 · 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
- 53,310 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
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RADIATION STERILIZED ADMIN. SET (K811078) | Travenol Laboratories, S.A. | 1981-07-02 |