Z-0070-2010

Unomedical Adult Manual Pulmonary Resuscitator, Adult Medium Mask w/ Reservoir Bag. Product ID # 779725

Name: Z-0070-2010 Unomedical Adult Manual Pulmonary Resuscitator, Adult Medium Mask w/ Reservoir Bag. Product ID # 779725
Creator: Unomedical
Published: 2009-10-06
License: https://open.fda.gov/license/

Unomedical A/S / initiated 2009-10-06 / Terminated / root cause: design

FDA source

Unomedical began a recall of Unomedical Adult Manual Pulmonary Resuscitator, Adult Medium Mask w/ Reservoir Bag. Product ID # 779725 on 2009-10-06. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0070-2010
Status: Terminated
Initiated: 2009-10-06
Posted: 2009-11-04
Terminated: 2010-08-10
Recalling firm: Unomedical A/S
Product: Unomedical Adult Manual Pulmonary Resuscitator, Adult Medium Mask w/ Reservoir Bag. Product ID # 779725
Product code: BTM Ventilator, Emergency, Manual (Resuscitator)
Reason for recall: 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 tag: design
FDA 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 sent to all customers and for returns, follow Distributor actions listed in the letter. Retailers and end users/Hospitals/EMT's are asked to perform a count of recalled product, segregate it and return the response form. All customers are asked to call 1-800-634-6003 where they will be assigned a RGA number and given instructions on how to return product. Contact information: 8:00AM - 5:30 PM Central Time Monday through Thursday and 8:00AM to 1:00 PM on Fridays, Central Time.
Quantity in commerce: over 200 total lots
Distribution: Worldwide distribution: USA, Argentina, Canada, Denmark, France, Greece, India, Italy, Japan, Mexico, Paraguay, Peru, Poland, Russia and Vietnam.
Product codes and lots: Product ID # 779725, lot code: 04-35

Product code BTM

K873286Class IIDisposable, Manual Pulmonary ResuscitatorHospitak, Inc. / cleared 1987-10-26

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)