Z-0971-2011

Bio Med Devices Disposable Pediatric Breathing Circuit, One Set, Catalog Number: 4040LC-9 9 foot /15mm...

Name: Z-0971-2011 Bio Med Devices Disposable Pediatric Breathing Circuit, One Set, Catalog Number: 4040LC-9 9 foot /15mm...
Creator: Biomed Devices
Published: 2010-10-19
License: https://open.fda.gov/license/

Bio-Med Devices, Inc. / initiated 2010-10-19 / Terminated

FDA source

Biomed Devices began a recall of Bio Med Devices Disposable Pediatric Breathing Circuit, One Set, Catalog Number: 4040LC-9 9 foot /15mm corrugated EVA hose Intended use: Breathing circuit is a... on 2010-10-19. The reason FDA records is "Breathing circuit may disconnect between the adapter adjacent tubing cuff". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0971-2011
Status: Terminated
Initiated: 2010-10-19
Posted: 2011-01-27
Terminated: 2014-10-23
Recalling firm: Bio-Med Devices, Inc.
Product: Bio Med Devices Disposable Pediatric Breathing Circuit, One Set, Catalog Number: 4040LC-9 9 foot /15mm corrugated EVA hose Intended use: Breathing circuit is a pediatric disposable tubing assembly for use with Lifecare ventilator
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: Breathing circuit may disconnect between the adapter adjacent tubing cuff
FDA 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 in commerce: 1 case (20/cs)
Distribution: Nationwide distribution: OH, WI.
Product codes and lots: Lot Number: 09072710

Product code CBK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)