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U.S. Department of Health and Human Services

Class 3 Device Recall Sharpoint Hydrodissection Cannula

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  Class 3 Device Recall Sharpoint Hydrodissection Cannula see related information
Date Initiated by Firm November 05, 2002
Date Posted February 05, 2003
Recall Status1 Terminated 3 on July 31, 2003
Recall Number Z-0544-03
Recall Event ID 25254
Product Classification Cannula, Surgical, General & Plastic Surgery - Product Code GEA
Product 25 Gauge Hydrodissection Cannula 1'' (25 mm) with U-Shaped Flattened End
Code Information Model Number of Device: 3425 Catalog Number: 3425 Lot number: MK10190 exp 11/2006
Recalling Firm/
Manufacturer		 Surgical Specialties Corp
100 Dennis Drive
Reading PA 19606-3776
For Additional Information Contact Judith A. Bradley
800-523-3332 Ext. 2218
Manufacturer Reason
for Recall		 The wrong product in the box.
FDA Determined
Cause 2		 Other
Action The domestic account was contacted via fax on 11/8/02 and 12/10/02. The foreign accounts were contacted via email on 11/5-12/02.
Quantity in Commerce 211 units
Distribution The product was sent to wholesalers in CA, Spain and Australia
Total Product Life Cycle TPLC 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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