—#93977

Product

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)

FDA product code: GAZ — Tubing, Noninvasive
Device class: Class 2
Medical specialty: General Hospital
Affected lot / code info: All lots prior to Y10Kxxxx

Why it was recalled

The packaging seals may not be intact, resulting in compromised sterility for the listed Medi-Vac Non-Conductive Tubing.

Root cause (FDA determination)

Other

Action the firm took

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 replacement " Distributors were instructed to conduct sub-recalls and return their inventory to Cardinal Health " To arrange for credit or replacement of the product destroyed, the accounts were instructed to call customer service at 800-964-5227 or 888-444-5440. " All customers were requested to complete the enclosed Recall Acknowledgment Form acknowledging receipt of the letter and the number of tubing units destroyed, and fax it to 847-689-9101. Cardinal Health can be contacted at 800-292-9332. Cardinal sent recall letters dated 8/26/10 to their PreSource kit/module customers via UPS next day air, informing them that the Medi-Vac Non-conductive Suction Tubing listed may have packaging seals that are compromised. The accounts were informed that Cardinal has inspected tubing packages in their warehouses and removed the affected products. All packages that have been inspected will have a 3/4" green dot on the front of each package. Enclosed with the recall letter were recall labels to affix to each affected Presource pack/module in the account's inventory. These labels instruct the user NOT to use the affected tubing component and to remove and discard the component upon opening the kit. The accounts were also requested to complete and fax back to Cardinal the enclosed reply sheet acknowledging receipt of the letter and the number of packs/modules on hand. Distributo

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution, including USA.

Timeline

Recall initiated: 2010-08-16
Posted by FDA: 2010-09-22
Terminated: 2011-11-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #93977. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.