Class 2 Device Recall Convertors Tiburon Cardiovascular Split Drape II

• Date Initiated by Firm: September 27, 2006
• Date Posted: October 21, 2006
• Recall Status: Terminated on May 09, 2008
• Recall Number: Z-0058-2007
• Recall Event ID: 36421
• Product Classification: Drape - Product Code KKX
• Product: Convertors Tiburon Cardiovascular Split Drape II, Sterile, for single use only; Cardinal Health, McGaw Park, IL 60085-6787, Made in Mexico The cardiovascular drapes were packagaged under the following configurations: a) Catalog #9158 - 1 CV split drape b) Catalog #9158CE - 8 x 1 CV split drape
• Code Information: Catalog #9158: lot numbers 06FRD326, 06FRD341, 06GRD006, 06GRD013 and 06HRD110; Catalog #9158CE: lot numbers 06FAD344, 06FAD370, 06FAD405, 06HAD109
• Recalling Firm/ Manufacturer: Cardinal Health; 1430 Waukegan Rd; Mc Gaw Park IL 60085-6726
• For Additional Information Contact: Michele B. Donatich R.N.; 800-292-9332
• Manufacturer Reason for Recall: The cardiovascular drape may tear and/or fray at the reinforced fenestrated trough area during use.
• FDA Determined Cause: Other
• Action: Cardinal Health sent separate recall letters dated 9/27/06 via UPS next day delivery to those accounts who ordered the drapes alone and those accounts who ordered custom sterile packs and PBDS modules, informing them that the cardiovascular split drapes may tear and/or fray at the reinforced fenestrated trough area during use. The letters listed the catalog numbers and affected lot numbers of the sterile drapes, and the letters sent to the pack and module customers were accompanied by a listing of catalog numbers and work order numbers for the affected packs ordered by each account. The accounts were requested to inspect their inventory to determine if they had any of the affected product on hand; segregate the affected inventories; complete and return via fax at 847-689-9101, the enclosed acknowledgment form, indicating the number of drapes in inventory being destroyed; and contact the El Paso Customer Service Center at 915-779-3681 to order replacement product. Distributors were requested to notify their customers of the recall. An additional letter dated 10/25/06 was sent via UPS overnight delivery to 49 of the accounts, expanding the recall to include lot 06HRD110 of catalog #9158, Convertors Tiburon Cardiovascular Split Drape II, Sterile. The instructions remained the same as those in the 9/27/06 letter.
• Quantity in Commerce: 1086 units
• Distribution: Worldwide Distribution- USA and countries of Kuwait 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.