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U.S. Department of Health and Human Services

Class 2 Device Recall Medline Anesth Circ Adult 40in Mask 3L Kit

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 Class 2 Device Recall Medline Anesth Circ Adult 40in Mask 3L Kitsee related information
Date Initiated by FirmMarch 18, 2005
Date PostedApril 27, 2005
Recall Status1 Terminated 3 on October 17, 2005
Recall NumberZ-0772-05
Recall Event ID 31528
Product Classification General Surgery Tray - Product Code LRO
ProductMedline 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
Code Information reorder number DYNJAA4749, lots 04KD1031, 05AD1865, 05CD0210
Recalling Firm/
Manufacturer		 Medline Industries, Inc.
1170 S Northpoint Blvd
Waukegan IL 60085-6757
For Additional Information ContactMs. Lara M. Simmons
800-879-2791 Ext. 6072
Manufacturer 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 Determined
Cause 2		Other
ActionRecalled 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 Commerce1,740 kits
DistributionCalifornia, Alabama, Minnesota, Florida and Indiana.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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