Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0772-05

Medline Custom Anesthesia Circuit Adult 40in Mask 3L Kit (non-sterile), reorder number DYNJAA4749; the kit...

MEDLINE INDUSTRIES, LP - Northfield / initiated 2005-03-18 / Terminated

Medline Industries, Inc. began a recall of Medline Custom Anesthesia Circuit Adult 40in Mask 3L Kit (non-sterile), reorder number DYNJAA4749; the kit contains the Nexus Adult Unilimb Circuit - 40''... on . The reason FDA records is "The procedure packs contain anesthesia/breathing circuits being recalled by MMS Sales due to partial occlusion of the T-piece resulting in airway obstruction". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0772-05
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Product
Medline Custom Anesthesia Circuit Adult 40in Mask 3L Kit (non-sterile), reorder number DYNJAA4749; the kit contains the Nexus Adult Unilimb Circuit - 40'', part C4N000D001, along with a 3 liter latex free breathing bag, adult medium anesthesia mask and poly bag; Made in USA by Medline Industries, Inc., Mundelein, IL 60060
Product code
LRO General Surgery Tray
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.
FDA root cause
Other
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.
Quantity in commerce
1,740 kits
Distribution
California, Alabama, Minnesota, Florida and Indiana.
Product codes and lots
reorder number DYNJAA4749, lots 04KD1031, 05AD1865, 05CD0210