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Terminated

Baxter Auto Syringe Micro-Volume Extension Set with 0.22 Micron Filter, catalog 1M8516 and 1M8516Y; Baxter Healthcare Corporation, Auto Syringe Division, Hookset, NH 03106

FDA Recall Z-0511-03 · Posted 2003-02-06

Recalling FirmBaxter Healthcare Corp.
Recall StatusTerminated
Product CodeFPA
Date Initiated2002-10-17
Date Terminated2004-02-04
Product Quantity16,860 units

Reason for Recall

The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.

Firm Action

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

Distribution Pattern

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 Kong and Nigeria.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K811078RADIATION STERILIZED ADMIN. SETTravenol Laboratories, S.A. · 1981-07-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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