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U.S. Department of Health and Human Services

Class 2 Device Recall Converters(R) Tiburon(R) Arthroscopy Drape

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  Class 2 Device Recall Converters(R) Tiburon(R) Arthroscopy Drape see related information
Date Initiated by Firm June 27, 2017
Date Posted July 07, 2017
Recall Status1 Terminated 3 on March 29, 2019
Recall Number Z-2758-2017
Recall Event ID 77686
Product Classification Drape, surgical - Product Code KKX
Product Converters(R) Tiburon(R) Arthroscopy Drape, REF 9414, STERILE EO, Qty. 1, Cardinal Health, Waukegan, IL
A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.
Code Information Lot 16LUS317, expires November 1, 2021
Recalling Firm/
Cardinal Health 200, LLC
1500 S Waukegan Rd
Waukegan IL 60085-6728
For Additional Information Contact Customer Advocacy
Manufacturer Reason
for Recall
Outer label of some units of product number/lot number 8482, Lot 16LFS235 and product number/lot number 9414, Lot 16LUS317 do not match the drape packaged inside.
FDA Determined
Cause 2
Mixed-up of materials/components
Action Cardinal Health sent an Urgent Product Recall letter dated June 27, 2017, to all affected consignees. In the letter, the firm requested the following actions be taken: 1. Inspect your inventory for the affected product code and lot number (listed on the package) 2. segregate and quarantine all on-hand product 3. Return the enclosed acknowledgment form via fax to 847-689-9101 ir614-652-9648, whether or not you have affected product, indicating the product code, lot and quantity of product you've quarantined or discarded. 4. Notify any customers to whom may have distributed or forwarded product affected by this product. 5. Contact the appropriate Customer Service group to arrange for return and credit of any affected product: Hospital - 800-964-5227 Federal Government - 800-444-1166 Distributor - 600-635-6021 All other customers - 888-444-5401 For questions regarding this recall call 800-327-7503.
Quantity in Commerce 528 each
Distribution Worldwide Distribution - US (Nationwide including PR) and Canada
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.