Recall Z-0070-2010 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
Unomedical
Unomedical Adult Manual Pulmonary Resuscitator, Adult Medium Mask w/ Reservoir Bag. Product ID # 779725
| Date | Nov 4, 2009 (initiated Oct 6, 2009) |
| Status | Terminated |
| Reason | In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose its ability to generate the positive pressure necessary necessary to ventilate the patient. |
| Root cause | Device Design |
| Action | Unomedical issued Press on October 6, 2009. Letters were sent to customers on October 7, 2009 via UPS - return receipt. Letters explained the reason for recall and the potential hazard to patients. The letter contains a list of all affected lot numbers as well as a picture which shows that units with a clearly visible blue ring are NOT affected. Distributors are asked to examine inventory and quarantine all affected product and return the response form, even if no recalled product is in inventory. If the product was further distributed, the letter requests that a copy of the letter be sen |
| Quantity | over 200 total lots |
| Distribution | Worldwide distribution: USA, Argentina, Canada, Denmark, France, Greece, India, Italy, Japan, Mexico, Paraguay, Peru, Poland, Russia and Vietnam. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K873286 | DISPOSABLE, MANUAL PULMONARY RESUSCITATOR Hospitak, Inc., Oct 26, 1987 |