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Terminated

Clearlink System Continu-Flo Solution Set, 10 drops/mL, 113'', 2 Luer Activated Valves, Male Luer Lock Adapter, catalog 2C8519; Baxter Healthcare Corporation, Deerfield, IL 60015 USA

FDA Recall Z-1156-03 · Posted 2003-08-21

Recalling FirmBaxter Healthcare Corp.
Recall StatusTerminated
Product CodeFPA
Date Initiated2003-07-16
Date Terminated2004-06-29
Product Quantity887,483 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.

K003225SOLUTION ADMINISTRATION SETS WITH CAPLESS LUER ACTIVATED VALVEBaxter Healthcare Corp · 2000-10-19

Official Source

View FDA Recall →

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

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