FDA Medical Device Recalls (openFDA)
Biomed Devices: 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
- Recall number
- Z-0972-2011
- Recalling firm
- Biomed Devices
- 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
- Status
- Terminated
- Initiated
- 2010-10-19
- Posted
- 2011-01-27
- Terminated
- 2014-10-23
- Reason
- Breathing circuit may disconnect between the adapter adjacent tubing cuff
- Root cause
- 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
- 15 cases (20/cs)
- Distribution
- Nationwide distribution: OH, WI.
- Lot, serial or model codes
- Lot Numbers: 09072210 09081310, 09082510, 05091510
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CBK
- Firm FEI
- 3003952420
- Firm city
- Guilford
- Firm state
- CT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28