Interlink System Solution Set with Microbore Tubing, 60 Drops/mL, 123'', 2 injection sites, Male Luer Lock Adapter, cata

FDA device recall Z-1151-03 · posted 2003-08-21 · Terminated

Recall details

Recalling firm

Baxter Healthcare Corp.

Reason for recall

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

Action taken

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

Status

Terminated

Product code

FPA

Quantity affected

6,192 units

Distribution

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

Date initiated

2003-07-16

Date posted

2003-08-21

Date terminated

2004-06-29

Location

Round Lake, IL

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