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U.S. Department of Health and Human Services

Class 2 Device Recall Portex

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 Class 2 Device Recall Portexsee related information
Date Initiated by FirmApril 01, 2004
Date PostedFebruary 01, 2005
Recall Status1 Terminated 3 on February 08, 2005
Recall NumberZ-0463-05
Recall Event ID 30642
ProductCustom Order Value Pack General Anesthesia Kit Catalog Number: VP1279 Labeled in part: CONTENTS: 1-Adult Disposable Anesthesia Breathing Circuit ***1-Breathing Bag Non-Latex***.
Code Information Lot Numbers: 205614, 223919, 504882
Recalling Firm/
Manufacturer		 Smiths Medical ASD, Inc.
10 Bowman Dr
Keene NH 03431-5043
For Additional Information ContactTimothy J. Talcott
603-352-3812
Manufacturer Reason
for Recall		Mislabeled: Product labeled as non-latex actually contains a latex breathing bag.
FDA Determined
Cause 2		Other
ActionSmiths Sales Representatives and Sales Regional Manager visited the distributor and removed 33 cases.
Quantity in Commerce357 cases
DistributionFL
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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