Recall Z-0971-2011 ยท CBK Ventilator, Continuous, Facility Use
Biomed Devices
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
| Date | Jan 27, 2011 (initiated Oct 19, 2010) |
| Status | Terminated |
| 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 th |
| Quantity | 1 case (20/cs) |
| Distribution | Nationwide distribution: OH, WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.