Recall Z-2459-2010 ยท GAZ Tubing, Noninvasive
Cardinal Health
All Presource Kits that contain Medi-Vac Non-Conductive Suction Tube with Maxi-Grip Connectors; Sterile, for single use only; Packaged by Cardinal Health, Medical Products and Services, McGaw Park, IL 60085 USA; Presource Kits are custom packaged kits that contain various products as requested by specific hospital it made for.
| Date | Sep 22, 2010 (initiated Aug 16, 2010) |
| Status | Terminated |
| Reason | The packaging seals may not be intact, resulting in compromised sterility for the listed Medi-Vac Non-Conductive Tubing. |
| Root cause | Other |
| Action | Cardinal Health issued an URGENT: PRODUCT RECALL letter dated August 16, 2010 to consignees, identifying the reason for the recall, the affected lots, and actions to be taken. Cardinal has inspected all packages in their warehouses and removed the affected products. All packages that have been inspected have a 3/4" green dot on the front of each unit and on the case carton label. " Cardinal Health end users were instructed to segregate and destroy their affected product and request credit or replacement " Distributor customers were instructed to destroy their product and request credit or rep |
| Distribution | Worldwide Distribution, including USA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.