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U.S. Department of Health and Human Services

Class 2 Device Recall Ventlabassembled Anesthesia breathing bags

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  Class 2 Device Recall Ventlabassembled Anesthesia breathing bags see related information
Date Initiated by Firm December 05, 2007
Date Posted September 20, 2008
Recall Status1 Terminated 3 on October 15, 2008
Recall Number Z-2324-2008
Recall Event ID 48958
Product Classification Reservoir bag - Product Code BTC
Product Ventlab-assembled Anesthesia breathing bags. The recall involves 3 Liter, 2 Liter and 1 Liter latex free bags used with Medline anesthesia circuit kits. The bags are sold in bulk.
Code Information (NC Facility): Part #720057B (3 Liter bags), Lot #63069, 64872, 65226, 66781, 67068, 67068; Part #720058B (2 Liter bags), Lot#63660, 64877, 65225, 68752; Part #720059B (1Liter bags), Lot#63661, 64878, 65227. (China Facility): Part #720057B, Lot #3B0001, 3B0002, 3B0005, 3B0004, 3B0005; Part #720059B, Lot #1B0001, 1B0002, 1B0003; and Part #720058B, Lot #2B0002
Recalling Firm/
Manufacturer		 Ventlab Corporation
155 Boyce Dr
Mocksville NC 27028-4187
For Additional Information Contact James A. Cochie
336-753-5000
Manufacturer Reason
for Recall		 During setup and potentially during procedures, the breathing bag can become separated from the taped bushing that is part of the breathing bag assembly.
FDA Determined
Cause 2		 Other
Action Medline Industries, Waukegan, IL was notified by letter titled URGENT - MEDICAL DEVICE RECALL on/about 12/05/2007. They were instructed to check their facility for any of the the affected product in inventory. If found they were advised to destroy and discard. They were to notify Ventlab of the disposition of the bags at their facility. Contact James Cochie at 336-753-5000 if you have questions.
Quantity in Commerce 571, 500 units
Distribution IL
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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