Hospitak Infant Manual Pulmonary Resuscitator with reservoir bag, face mask & swivel Gas sampling elbow. foreign Distrib

FDA device recall Z-0057-2010 · posted 2009-11-04 · Terminated

Recall details

Recalling firm

Unomedical

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.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

BTM

Quantity affected

over 200 total lots

Distribution

Worldwide distribution: USA, Argentina, Canada, Denmark, France, Greece, India, Italy, Japan, Mexico, Paraguay, Peru, Poland, Russia and Vietnam.

Date initiated

2009-10-06

Date posted

2009-11-04

Date terminated

2010-08-10

Location

Mcallen, TX

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