—#48627

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

FDA product code: KKX — Drape, Surgical
Device class: Class 2
Medical specialty: General, Plastic Surgery
Affected lot / code info: Catalog #9158: lot numbers 06FRD326, 06FRD341, 06GRD006, 06GRD013 and 06HRD110; Catalog #9158CE: lot numbers 06FAD344, 06FAD370, 06FAD405, 06HAD109

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Cardinal Health
Address: 1430 Waukegan Rd, Mc Gaw Park, Illinois 60085-6726

Distribution

Distribution pattern: Worldwide Distribution- USA and countries of Kuwait and Australia

Timeline

Recall initiated: 2006-09-27
Posted by FDA: 2006-10-21
Terminated: 2008-05-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #48627. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.