FDA Medical Device Recalls (openFDA)
Cardinal Health 200, LLC: Cardinal Health MEDI-VAC CRD Suction Canister Liner, 1000 mL Suction Canister Liner Kit with 5 mm 1.8 m Tube, REF 65651-516
- Recall number
- Z-0755-2024
- Recalling firm
- Cardinal Health 200, LLC
- 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
- Status
- Open, Classified
- Initiated
- 2023-12-21
- Posted
- 2024-01-18
- Terminated
- not on file
- Reason
- 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
- 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: GMB-FieldCorrectiveAction@cardinalhealth.com or call 800-292-9332.
- Quantity
- 203244 units
- Distribution
- US, Canada, Australia and New Zealand
- Lot, serial or model codes
- 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
- 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