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U.S. Department of Health and Human Services

Class 3 Device Recall Centurion Healthcare Products Arthrogram Tray

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  Class 3 Device Recall Centurion Healthcare Products Arthrogram Tray see related information
Date Initiated by Firm October 26, 2007
Date Posted February 23, 2008
Recall Status1 Terminated 3 on March 13, 2008
Recall Number Z-0730-2008
Recall Event ID 46155
510(K)Number K012736  
Product Classification Surgical Disposable Instrument - Product Code KDC
Product Centurion Healthcare Products Laceration Tray, sterile; (Reorder SUT8805A) Tri-State Hospital Supply Co., Howell, MI. 48844. The primary kit is labeled as containing 1 needle, 21G x 1-1/2", among other components, however some kits may contain a 21Gx1" needle. The label on the Kendall Monoject Magellan 21G Safety Needle itself is the correct size.
Code Information Lot Number: 907097.
Recalling Firm/
Manufacturer		 Tri-State Hospital Supply Corporation
301 Catrell Drive
Howell MI 48843
For Additional Information Contact
517-546-5400
Manufacturer Reason
for Recall		 Incorrect Needle size - Some of the kits contain a 1 inch 21G needle instead of the 1-1/2 inch 21 needle specified on the kit label.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action An Urgent Product Recall Notice was sent on October 25, 2007 to Distributors, Distributors customers, and all third party consignee. The letter provided information concerning the product recall, and requested removal of all product inventory. A product return form requesting information on products still in the facility was enclosed. A Tri-State Representative will be in contact regarding retrieval of the product.
Quantity in Commerce 396 kits.
Distribution Nationwide Distribution, including states of Massachusetts and Washington.
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.
510(K) Database 510(K)s with Product Code = KDC and Original Applicant = TYCO HEALTHCARE
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