CardinalHealth Suction Canister Liner, MEDI-VAC CRD, REF 65651-510
This recall is currently active, issued January 18, 2024. It was issued by Cardinal Health 200, Llc.
- Company
- Cardinal Health 200, Llc
- Recall Initiated
- December 21, 2023
- Posted
- January 18, 2024
- Recall Number
- Z-0754-2024
- Quantity
- 3505730 units
- Firm Location
- Waukegan, IL
- Official Source
- View on FDA website ↗
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.
Distribution
US, Canada, Australia and New Zealand
Lot / Code Info
UDI/DI 50630140152649 (case), Lot Numbers: J308-602, J308-605, J308-609, J308-623, J308-624, J308-625, J308-628, J308-629, J308-630, J308-632, J308-633, J308-634, J308-635, J308-636, J308-637, J308-640, J308-642, J308-607, J308-643, J309-603, J309-607, J309-623, J309-627, J309-630, J309-632, J309-635, J309-636, J309-637, J310-601, J310-609, J310-621, J310-622, J310-626, J310-627, J310-641, J310-642, J310-643, J310-644
Root Cause
Process control
Action Taken
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.