FDA Enforcement
Class II
Ongoing
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: Z-0755-2024
·
Reported January 24, 2024
Enforcement
- Recall Number
- Z-0755-2024
- Event ID
- 93628
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Cardinal Health 200, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 24, 2024
- Initiation Date
- December 21, 2023
- Classification Date
- January 18, 2024
- Address
- 3651 Birchwood Dr, N/A, Waukegan, IL, 60085-8337, United States
Description
Cardinal Health MEDI-VAC CRD Suction Canister Liner, 1000 mL Suction Canister Liner Kit with 5 mm 1.8 m Tube, REF 65651-516
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.
Code Info
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
Distribution
US, Canada, Australia and New Zealand
Quantity
203244 units