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U.S. Department of Health and Human Services

Class 1 Device Recall Hospitak

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 Class 1 Device Recall Hospitaksee related information
Date Initiated by FirmDecember 02, 2004
Date PostedDecember 08, 2004
Recall Status1 Terminated 3 on September 07, 2006
Recall NumberZ-0289-05
Recall Event ID 30526
Product Classification Connector, Airway (Extension) - Product Code BZA
ProductViasys, REF BLD-1000, Pulmanex Adapter 22mm O.D. x 22mm O.D. x 15 mm I.D., manufactured by Unomedical, Inc of McAllen, Texas and assembled in Mexico
Code Information Lot numbers 27904001 and 29504001
Recalling Firm/
Manufacturer		 Unomedical, Inc
6001 S 35th St
Mcallen TX 78503-8887
Manufacturer Reason
for Recall		Adapters have been found to be blocked or occluded - potentially preventing exhalation or inhalation
FDA Determined
Cause 2		Other
ActionThe 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.
Quantity in Commerce34 cases; 50 units/case (1,700 units total)
DistributionThe product was distributed nationwide to hospitals, home healthcare, and medical transport. Distribution to foreign countries included: Canada; Russia; France; Switzerland; Argentina; Uruguay; and Mexico
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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