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U.S. Department of Health and Human Services

Class 2 Device Recall Bulk NonSterile Cardiovascular Split Drape II

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  Class 2 Device Recall Bulk NonSterile Cardiovascular Split Drape II see related information
Date Initiated by Firm September 27, 2006
Date Posted October 21, 2006
Recall Status1 Terminated 3 on May 09, 2008
Recall Number Z-0061-2007
Recall Event ID 36421
Product Classification Drape - Product Code KKX
Product Cardiovascular Split Sheet II, Bulk Non-Sterile; 130 units per box; Cardinal Health, McGaw Park, IL 60085-6787, Made in Mexico; catalog #9158N
Code Information catalog #9158, lot numbers 17362D; 17361D; 17461D; 17761D; 17762D; 17861D; 17961D; 18061D; 18861D; 19362D; 19461D; 19462D; 19561D; 19862D; 19961D; 21262D; 22861D; 22862D; 22961D; 23361D; 23562D; 23761D.
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 2
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 1982 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.
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