Z-2456-2010

Medi-Vac Non-Conductive Suction Tube with Maxi-Grip Connectors, Inner Diameter: 7 mm (9/32"), Length: 1.8 m...

Name: Z-2456-2010 Medi-Vac Non-Conductive Suction Tube with Maxi-Grip Connectors, Inner Diameter: 7 mm (9/32"), Length: 1.8 m...
Creator: Cardinal Health
Published: 2010-08-16
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2010-08-16 / Terminated / root cause: packaging

FDA source

Cardinal Health began a recall of Medi-Vac Non-Conductive Suction Tube with Maxi-Grip Connectors, Inner Diameter: 7 mm (9/32"), Length: 1.8 m (6 ft.); Sterile, for single use only, 50 tubes per... on 2010-08-16. The reason FDA records is "The packaging seals may not be intact, resulting in compromised sterility for the listed Medi-Vac Non-Conductive Tubing". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2456-2010
Status: Terminated
Initiated: 2010-08-16
Posted: 2010-09-22
Terminated: 2011-11-28
Recalling firm: Medtronic, Inc.
Product: Medi-Vac Non-Conductive Suction Tube with Maxi-Grip Connectors, Inner Diameter: 7 mm (9/32"), Length: 1.8 m (6 ft.); Sterile, for single use only, 50 tubes per case; Cardinal Health, McGaw Park, IL 60085 USA, Made in Mexico; catalog N76A and NEX76A (European label)
Product code: GAZ Tubing, Noninvasive
Reason for recall: The packaging seals may not be intact, resulting in compromised sterility for the listed Medi-Vac Non-Conductive Tubing.
Root cause tag: packaging
FDA 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 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
Distribution: Worldwide Distribution, including USA.
Product codes and lots: All lots prior to Y10Kxxxx

Product code GAZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)