Convertors Cardiovascular Split Pack II, the pack contains 1 Tiburon Cardiovascular Split Drape II and 3 Astound Surgica

FDA device recall Z-0059-2007 · posted 2006-10-21 · Terminated

Recall details

Recalling firm

Cardinal Health

Reason for recall

The cardiovascular drape may tear and fray at the reinforced fenestrated trough area during use.

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.

Root cause

Other

Status

Terminated

Product code

LRO

Quantity affected

633 packs

Distribution

Worldwide Distribution- USA and countries of Kuwait and Australia

Date initiated

2006-09-27

Date posted

2006-10-21

Date terminated

2008-05-09

Location

Park, IL