FDA Medical Device Recalls (openFDA)
Cardinal Health: Convertors Cardiovascular Split Pack II, the pack contains 1 Tiburon Cardiovascular Split Drape II and 3 Astound Surgical Gowns; Sterile, for single use only; Cardinal Health, McGaw Park, IL 60085-6787, Made in Mexico; Catalog #29158
- Recall number
- Z-0059-2007
- Recalling firm
- Cardinal Health
- Product
- Convertors Cardiovascular Split Pack II, the pack contains 1 Tiburon Cardiovascular Split Drape II and 3 Astound Surgical Gowns; Sterile, for single use only; Cardinal Health, McGaw Park, IL 60085-6787, Made in Mexico; Catalog #29158
- Status
- Terminated
- Initiated
- 2006-09-27
- Posted
- 2006-10-21
- Terminated
- 2008-05-09
- Reason
- The cardiovascular drape may tear and fray at the reinforced fenestrated trough area during use.
- Root 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
- 633 packs
- Distribution
- Worldwide Distribution- USA and countries of Kuwait and Australia
- Lot, serial or model codes
- Catalog #29158: lot numbers 06FAD300, 06FDA304, 06FAD378, 06FAD386, 06HAD299, 06HAD462, 06HAD485
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LRO
- Firm FEI
- 3001236905
- Firm city
- Park
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28