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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 FirmJuly 02, 2004
Date PostedJuly 30, 2004
Recall Status1 Terminated 3 on May 02, 2006
Recall NumberZ-1253-04
Recall Event ID 29490
Product Classification Anesthesia Conduction Kit - Product Code CAZ
Product15646-20 SPINAL(DD) 27G WHITACRE W/DRUGS
Code Information Lot Number: K517586 
Recalling Firm/
Manufacturer
Smiths Medical ASD, Inc.
10 Bowman Dr
Keene NH 03431-5043
Manufacturer Reason
for Recall
Trays contain Hospira recalled 2ml drug ampuls of 5% Lidocaine Hydrochloride with 7.5% Dextrose Injection, (NDC 0074-4712-01, lot number 09-568-DK) Hospira, Inc. was recalling the 2ml drug vials of 5% Lidocaine Hydrochloride w/ 7.5% Dextrose lot number 09-568-DK). The drug is being recalled due to reports of particulate in the product.
FDA Determined
Cause 2
Other
ActionSmiths Medical notifed Dealers and direct customers were contacted via letter delivered by Federal Express on July 2, 2004. Customers and dealers are directed to fax back the attached Reply Letter
Quantity in Commerce500 units
DistributionNationwide
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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