Recall Z-0058-2007 ยท KKX Drape, Surgical, Antimicrobial
Cardinal Health
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
| Date | Oct 21, 2006 (initiated Sep 27, 2006) |
| Status | Terminated |
| Reason | The cardiovascular drape may tear and/or 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 accou |
| Quantity | 1086 units |
| Distribution | Worldwide Distribution- USA and countries of Kuwait and Australia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.