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U.S. Department of Health and Human Services

Class 2 Device Recall Gertie Marx PainPak

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 Class 2 Device Recall Gertie Marx PainPaksee related information
Date Initiated by FirmJune 18, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on October 20, 2004
Recall NumberZ-1113-04
Recall Event ID 29389
Product Classification General Surgery Tray - Product Code LRO
ProductGertie Marx PainPak, Lot number 0504305, Reorder number 4060
Code Information Lot 0504305
FEI Number 1000306134
Recalling Firm/
Manufacturer		 Spinal Specialties, Inc
12001 Network Blvd Bldg F # 208
San Antonio TX 78249-3351
Manufacturer Reason
for Recall		Kit contains lidocaine, which has particulate matter in its ampule.
FDA Determined
Cause 2		Other
ActionFirm notified consignees who received the product by telephone on 6/18/2004, then sent a letter via facsimile and next day air delivery.
Quantity in Commerce60 units
DistributionEl Paso, Texas and Lansing, Michigan
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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