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Terminated

Baxter Y-Type Blood/Solution Set, 10 drops/mL, 112'', Standard Blood Filter, 170 to 260 Micron Filter, Injection Site, Male Luer Lock Adapter, catalog 2C6750; Baxter Healthcare Corporation, Deerfield, IL 60015 USA

FDA Recall Z-1160-03 · Posted 2003-08-21

Recalling FirmBaxter Healthcare Corp.
Recall StatusTerminated
Product CodeBRZ
Date Initiated2003-07-16
Date Terminated2004-06-29
Product Quantity83,664 units

Reason for Recall

There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.

Firm Action

Recalled by letter dated 7/16/03. The accounts were informed of the potential for leaks in the set tubing, and asked to inspect their inventory for the affected product codes and lots, segregate any affected products found and discard them according to local procedures. The customers will receive credit for the discarded affected product.

Root Cause

Other

Distribution Pattern

Nationwide, Mexico, Canada, Columbia, Australia, New Zealand and Taiwan

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K993120MODIFIED BLOOD RECIPIENT SETBaxter Healthcare Corp · 1999-11-17

Official Source

View FDA Recall →

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

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