Baxter Minivolume Extension Set, 36'', product code 2C5685; An Rx sterile, nonpyrogenic fluid pathway, 36'', 0.9 mL Vol.

FDA device recall Z-1426-05 · posted 2005-08-30 · Terminated

Recall details

Recalling firm

Baxter Healthcare Corp.

Reason for recall

The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.

Action taken

Baxter sent Urgent Product Recall letters dated 8/3/05 to their customers, to the attention of the Director of Materials Management, via first class mail on the same date. The accounts were informed of the microbore female luers that may crack during use, resulting in the possible under delivery or incomplete delivery of medication. The accounts were instructed to examine their inventory for the affected lots of product, remove it from inventory and return it to Baxter for credit. Any questions were directed to the Center for One Baxter at 1-800-422-9837. Baxter extended the recall to include additional lots via letter dated 12/15/05. The letters referenced the 8/3/05 letter, including a copy of that letter, and listed the affected lots of sets. The instructions for return of the product remained the same as that described in the 8/3/05 letter.

Root cause

Other

Status

Terminated

Product code

FPA

Quantity affected

96,105 sets

Distribution

Nationwide, including Puerto Rico and American Samoa, and internationally to Canada, Australia, Japan, South Korea, Saudi Arabia, India, Mexico, Venezuela, Malaysia, East Timor and New Zealand.

Date initiated

2005-08-03

Date posted

2005-08-30

Date terminated

2008-08-18

Location

Round Lake, IL

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