Z-1546-2018Class II

Medi-Vac(TM) Flex Advantage(TM) Suction Canister Liner, Material Numbers: a) REF 6561-910C b) REF 6561-916K...

Name: Z-1546-2018 Medi-Vac(TM) Flex Advantage(TM) Suction Canister Liner, Material Numbers: a) REF 6561-910C b) REF 6561-916K...
Creator: Cardinal Health 200, LLC
Published: 2018-03-28
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2018-03-28 / Terminated / root cause: manufacturing process

FDA source

Cardinal Health 200, LLC began a recall of Medi-Vac(TM) Flex Advantage(TM) Suction Canister Liner, Material Numbers: a) REF 6561-910C b) REF 6561-916K c) REF 6561-920C To remove blood and/or body... on 2018-03-28. FDA classified it as Class II and gives the reason as "products may be missing a one-way valve on the fluid patient port". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1546-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-28
Posted: 2018-04-30
Terminated: 2018-11-29
Recalling firm: Medtronic, Inc.
Product: Medi-Vac(TM) Flex Advantage(TM) Suction Canister Liner, Material Numbers: a) REF 6561-910C b) REF 6561-916K c) REF 6561-920C To remove blood and/or body fluids. These fluids may be suctioned during surgical procedures or other applications requiring the removal of built up fluids. The suction canisters are used in operating rooms but are also used outside the surgical field as well as post-operatively within patient suites. The collection containers hold the fluids until they are ready for proper disposal. Sources of vacuum range from wall suction (central vacuum piped throughout the healthcare facility) to liposuction devices (portable suction pumps).
Product code: GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Reason for recall: products may be missing a one-way valve on the fluid patient port.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Cardinal Health sent an Urgent Product Recall letter dated March 28, 2018, Please take the following actions: 1. INSPECT your inventory for the affected product code and lot number (listed on package) 2. SEGREGATE and QUARANTINE all on-hand product 3. RETURN the enclosed acknowledgment form via fax to 847-689-9101 or 614-652- 9648, whether or not you have affected product, indicating the product code, lot and quantity of product you've quarantined 4. CONTACT Customer Service at 800-964-5227 to arrange for return and credit of any affected product . For further questions, please call (800) 292- 9332.
Quantity in commerce: 3600 units
Distribution: US Distribution to the state of MA
Product codes and lots: a) REF 6561-910C, Lot Numbers: J802-384, J802-391 b) REF 6561-916K, Lot Number: J802-386 c) REF 6561-920C, Lot Number: J802-396

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1546-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1546-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-09	2018-04-30

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)