Z-0755-2024Class II

Cardinal Health MEDI-VAC CRD Suction Canister Liner, 1000 mL Suction Canister Liner Kit with 5 mm 1.8 m Tube...

Name: Z-0755-2024 Cardinal Health MEDI-VAC CRD Suction Canister Liner, 1000 mL Suction Canister Liner Kit with 5 mm 1.8 m Tube...
Creator: Cardinal Health 200, LLC
Published: 2023-12-21
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2023-12-21 / Open, Classified / root cause: manufacturing process

FDA source

Cardinal Health 200, LLC began a recall of Cardinal Health MEDI-VAC CRD Suction Canister Liner, 1000 mL Suction Canister Liner Kit with 5 mm 1.8 m Tube, REF 65651-516 on 2023-12-21. FDA classified it as Class II and gives the reason as "The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience loss of suction on low or low intermittent suction settings, due to a misalignment of the liner with the outer hard...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0755-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-12-21
Posted: 2024-01-18
Recalling firm: Medtronic, Inc.
Product: Cardinal Health MEDI-VAC CRD Suction Canister Liner, 1000 mL Suction Canister Liner Kit with 5 mm 1.8 m Tube, REF 65651-516
Product code: GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Reason for recall: The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience loss of suction on low or low intermittent suction settings, due to a misalignment of the liner with the outer hard canister.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Cardinal Health issued an URGENT MEDICAL DEVICE PRODUCT CORRECTION notice to its consignees on 12/21/2023 via overnight delivery. The notice explained the issue with the product and requested the consignee post a copy of Attachment A in the storeroom and clinical areas which provides the following information: Please take the following actions: "" Inspect liner for misalignment with the outer hard canister during setup. The misalignment can be seen visually during setup as the liner not sitting properly within the canister and can be felt by a springing back of the liner from the outer canister. o Reference illustration below " Test suction prior to use to ensure the 1L canister liner is working properly on low or low intermittent suction. " Monitor intermittent suctioning during use to ensure it is functioning properly. If suction is lost when using the 1L suction canister liner, apply a downward force by adding weight or by pressing down on the canister lid manually to reseal the canister; suction capability should restore.: Questions: CONTACT the appropriate Customer Service group with questions related to this notification. Monday Friday between 8:00am - 5pm EST: " Hospital 800-965-5227 " Federal Government 800-444-1166 " Distributor 800-635-6021 " All Other Customers 888-444-5440 For questions related to this notification and/or acknowledgement form that are not adequately addressed in this letter, please contact the market action team at: [email protected] or call 800-292-9332.
Quantity in commerce: 203244 units
Distribution: US, Canada, Australia and New Zealand
Product codes and lots: 50630140152633 (case), Lot Numbers: J308-606, J308-624, J308-628 J308-642, J308-643, J309-608, J309-610, J309-622, J309-626, J309-633, J309-645, J310-602, J310-617, J310-645

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0755-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0754-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-24	2024-01-18
Z-0755-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-24	2024-01-18
Z-0756-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-24	2024-01-18

Product code GCX

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)