—#38088

Product

Medline Custom Anesthesia Super Circuit Adult 60 Unilimb Kit (non-sterile), reorder number DYNJAAF6267; the kit contains the Nexus Adult Unilimb Circuit - 60'', part 60010-1B, along with a 3 liter latex breathing bag, anesthesia tubing clip, suction catheter, adult anesthesia mask, suction canister, drawstring poly bag and poly bag; Made in USA by Medline Industries, Inc., Mundelein, IL 60060

FDA product code: LRO — General Surgery Tray
Device class: Class 2
Medical specialty: General, Plastic Surgery
Affected lot / code info: reorder number DYNJAAF6267, lots 04LD1288, 04LD1865, 05CD0012, 05CD0467

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Medline Industries, Inc.
Address: 1170 S Northpoint Blvd, Waukegan, Illinois 60085-6757

Distribution

Distribution pattern: California, Alabama, Minnesota, Florida and Indiana.

Timeline

Recall initiated: 2005-03-18
Posted by FDA: 2005-04-27
Terminated: 2005-10-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #38088. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.