ClearanceBrief
Recall Z-2455-2010 ยท GAZ Tubing, Noninvasive

Cardinal Health

Medi-Vac Non-Conductive Suction Tube with Maxi-Grip Connectors, Inner Diameter: 6 mm (1/4"), Length: 3.6 m (12 ft.); Sterile, for single use only, 50 tubes per case; Cardinal Health, McGaw Park, IL 60085 USA, Made in Mexico; catalog N612 and NEX612 (European label)

DateSep 22, 2010 (initiated Aug 16, 2010)
StatusTerminated
ReasonThe packaging seals may not be intact, resulting in compromised sterility for the listed Medi-Vac Non-Conductive Tubing.
Root causeOther
ActionCardinal 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
DistributionWorldwide Distribution, including USA.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.