| | Class 2 Device Recall Cardinal Health MediVac CRD Suction Canister Liners |  |
| Date Initiated by Firm | December 21, 2023 |
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| Date Posted | January 18, 2024 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0754-2024 |
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| Recall Event ID |
93628 |
| Product Classification |
Apparatus, suction, operating-room, wall vacuum powered - Product Code GCX
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| Product | CardinalHealth Suction Canister Liner, MEDI-VAC CRD, REF 65651-510 |
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| Code Information |
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 |
| FEI Number |
3001236905
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Recalling Firm/
Manufacturer |
Cardinal Health 200, LLC
3651 Birchwood Dr
Waukegan IL 60085-8337
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| For Additional Information Contact |
847-887-5500 |
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Manufacturer 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. |
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FDA Determined
Cause 2 | Process control |
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| 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. |
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| Quantity in Commerce | 3505730 units |
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| Distribution | US, Canada, Australia and New Zealand |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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