Unomedical REF 962MM, Adapter 22mm/15mm, manufactured by Unomedical, Inc of McAllen, Texas and assembled in Mexico
FDA device recall Z-0292-05 · posted 2004-12-08 · Terminated
Recall details
- Recalling firm
- Unomedical, Inc
- Reason for recall
- Adapters have been found to be blocked or occluded - potentially preventing exhalation or inhalation
- Action taken
- The firm issued a Public Safety Alert on 11/30/2004. The firm expanded their safety alert on 12/02/2004 and issued press informing of a recall. The firm sent recall letters to consignees on 12/02/2004.
- Root cause
- Other
- Status
- Terminated
- Product code
- BZA
- Quantity affected
- 216 cases; 50 units/case (10,800 units total)
- Distribution
- The product was distributed nationwide to hospitals, home healthcare, and medical transport. Distribution to foreign countries included: Canada; Russia; France; Switzerland; Argentina; Uruguay; and Me
- Date initiated
- 2004-12-02
- Date posted
- 2004-12-08
- Date terminated
- 2006-09-07
- Location
- Mcallen, TX
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