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U.S. Department of Health and Human Services

Class 2 Device Recall Medline Anesth Circuit 40in Adult Uni Kit

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  Class 2 Device Recall Medline Anesth Circuit 40in Adult Uni Kit see related information
Date Initiated by Firm March 18, 2005
Date Posted April 27, 2005
Recall Status1 Terminated 3 on October 17, 2005
Recall Number Z-0774-05
Recall Event ID 31528
Product Classification General Surgery Tray - Product Code LRO
Product Medline Custom Anesthesia Circuit 40in Adult Unilimb Kit (non-sterile), reorder number DYNJAA4315; the kit contains the Nexus Adult Unilimb Circuit - 40'', part C4N012100, along with a 3 liter latex breathing bag, adult large anesthesia mask, gas line and poly bag; Made in USA by Medline Industries, Inc., Mundelein, IL 60060
Code Information reorder number DYNJAA4315, lots 04LD3310, 05AD0830
Recalling Firm/
Manufacturer		 Medline Industries, Inc.
1170 S Northpoint Blvd
Waukegan IL 60085-6757
For Additional Information Contact Ms. 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
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 2,120 kits
Distribution California, Alabama, Minnesota, Florida and Indiana.
Total Product Life Cycle TPLC 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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