CRD recallZ-0756-2024 · Cardinal Health 200, LLC · initiated Dec 21, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Cardinal Health 200, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-0756-2024
- Status
- Open, Classified
- Initiated by the company
- Dec 21, 2023
- Posted by the FDA
- Jan 18, 2024
- Recalling firm
- Cardinal Health 200, LLC
- Quantity
- 74515
- Product code
- GCX
- Distribution
- US, Canada, Australia and New Zealand
Product description
Cardinal Health Suction Canister Liner, MEDI-VAC CRD 1000 mL Suction Canister Liner Kit with 6 mm 1.8 m Tube, REF 65651-517
Code information (models, lots, serial numbers)
50630140152670 (case), Lot Numbers: J308-625, J308-629, J308-637, J309-616, J309-634, J309-646, J309-647, J310-603, J310-618
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- CRD 65651-517Cardinal Health 200, LLC · APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 93628).
- Z-0754-2024 · Open, ClassifiedCardinalHealth Suction Canister Liner, MEDI-VAC CRD, REF 65651-510
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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