FDA Medical Device Recalls (openFDA)
Cardinal Health 200, LLC: 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).
- Recall number
- Z-1546-2018
- Recalling firm
- Cardinal Health 200, LLC
- 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).
- Status
- Terminated
- Initiated
- 2018-03-28
- Posted
- not on file
- Terminated
- 2018-11-29
- Reason
- products may be missing a one-way valve on the fluid patient port.
- 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
- 3600 units
- Distribution
- US Distribution to the state of MA
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GCX
- Firm FEI
- 3001236905
- Firm city
- Waukegan
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28