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U.S. Department of Health and Human Services

Class 2 Device Recall Bio Med Devices

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  Class 2 Device Recall Bio Med Devices see related information
Date Initiated by Firm October 19, 2010
Date Posted January 27, 2011
Recall Status1 Terminated 3 on October 23, 2014
Recall Number Z-0972-2011
Recall Event ID 57051
Product Classification Ventilator, continuous, facility use - Product Code CBK
Product Bio Med Devices Disposable Pediatric Breathing Circuit, One Set
Catalog Number: 4040LC
5 foot /15mm corrugated EVA hose

Intended use: Breathing circuit is a pediatric disposable tubing assembly for use with Lifecare ventilators
Code Information Lot Numbers:  09072210 09081310, 09082510, 05091510
Recalling Firm/
Manufacturer		 Biomed Devices
61 Soundview Rd
Guilford CT 06437-2937
Manufacturer Reason
for Recall		 Breathing circuit may disconnect between the adapter adjacent tubing cuff
FDA Determined
Cause 2		 Component change control
Action The firm,Bio Med Devices, sent a "URGENT MEDICAL DEVICE RECALL" letter dated October 18, 2010 via fax to the customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to immediately examine their stock for the affected lots, if found, discontinue distributing and using the product and promptly return via UPS #025106 to Bio-Med Devices 61 Soundview Rd, Guilford, CT 06437, Attention: 4040LC Recall Return. The customers were also instructed to immediately contact their accounts, if the product was further distributed , advise them of the recall situation and have their outstanding product returned, and to complete and return the RETURN FAX-IMMEDIATE RESPONSE REQUIRED form via fax to 203-458-0440. Note: Bio-Med informed the customers that they will credit the return product; however, they only plan to replace the product in an emergency situation, because they have very few of the 3/8" x 15mm adapters left and are looking to discontinue the 4040LC due to the discontinuance of this product by the manufacturer. If you have any questions, please contact (203) 458-0202 x 217.
Quantity in Commerce 15 cases (20/cs)
Distribution Nationwide distribution: OH, WI.
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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