Cardiovascular Split Sheet II, Bulk Non-Sterile; 130 units per box; Cardinal Health, McGaw Park, IL 60085-6787, Made in Mexico; catalog #9158N
This recall has been terminated (originally issued October 21, 2006).
- Company
- Cardinal Health
- Recall Initiated
- September 27, 2006
- Posted
- October 21, 2006
- Terminated
- May 9, 2008
- Recall Number
- Z-0061-2007
- Quantity
- 1982 units
- Firm Location
- Mc Gaw Park, IL
- Official Source
- View on FDA website ↗
Reason for Recall
The cardiovascular drape may tear and/or fray at the reinforced fenestrated trough area during use.
Distribution
Worldwide Distribution- USA and countries of Kuwait and Australia
Lot / Code Info
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.
Root Cause
Other
Action Taken
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.