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Terminated

Medline Custom Anesthesia Circuit 40in Adult Unilimb Kit (non-sterile), reorder number DYNJAAF4304B; the kit contains the Nexus Adult Unilimb Circuit - 40'', part C4N012100, along with a 3 liter latex free breathing bag, gas sampling coestrud and poly bag; Made in USA by Medline Industries, Inc., Mundelein, IL 60060

FDA Recall Z-0773-05 · Posted 2005-04-27

Recalling FirmMedline Industries, Inc.
Recall StatusTerminated
Product CodeLRO
Date Initiated2005-03-18
Date Terminated2005-10-17
Product Quantity4,260 kits

Reason for Recall

The procedure packs contain anesthesia/breathing circuits being recalled by MMS Sales due to partial occlusion of the T-piece resulting in airway obstruction.

Firm Action

Recalled from the direct account hospitals via letter dated 3/18/05 and 3/23/05. The letters informed the accounts of the occlusion via copy of the MMS recall letter, and listed the Medline reorder number and lot numbers of the custom packs shipped to them, along with the MMS part number contained there in. The accounts were requested to examine their stocks for the affected codes and return them to Medline.

Root Cause

Other

Distribution Pattern

California, Alabama, Minnesota, Florida and Indiana.

Official Source

View FDA Recall →

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

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