Bio Med Devices Disposable Pediatric Breathing Circuit, One Set Catalog Number: 4040LC 5 foot /15mm corrugated EVA hose

FDA device recall Z-0972-2011 · posted 2011-01-27 · Terminated

Recall details

Recalling firm

Biomed Devices

Reason for recall

Breathing circuit may disconnect between the adapter adjacent tubing cuff

Action taken

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.

Root cause

Component change control

Status

Terminated

Product code

CBK

Quantity affected

15 cases (20/cs)

Distribution

Nationwide distribution: OH, WI.

Date initiated

2010-10-19

Date posted

2011-01-27

Date terminated

2014-10-23

Location

Guilford, CT