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U.S. Department of Health and Human Services

Class 2 Device Recall Spinal Specialties

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 Class 2 Device Recall Spinal Specialtiessee related information
Date Initiated by FirmApril 15, 2005
Date PostedJune 14, 2005
Recall Status1 Terminated 3 on November 02, 2005
Recall NumberZ-0885-05
Recall Event ID 31950
Product Classification Anesthesia Conduction Kit - Product Code CAZ
ProductClinical Technologies, Inc., 25 G Spinal Painpak, Reorder No.:4043, kit manufactured by Integra Spinal Specialties, San Antonio, Texas.
Code Information Lot number 1004328
Recalling Firm/
Manufacturer		 Spinal Specialties, Inc
12001 Network Blvd Bldg F # 208
San Antonio TX 78249-3351
Manufacturer Reason
for Recall		Becton Dickinson recalled the needles due to reports of leakage associated with an undersized Luer taper in the spinal needle hub.
FDA Determined
Cause 2		Other
ActionThe firm initiated the recall via letter on April 15, 2005.
Quantity in Commerce100 kits
DistributionVA, OH, TX, CA, IL, and FL
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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