Z-1546-2018 Class II Terminated
FDA device recall Z-1546-2018 was initiated by Cardinal Health 200, LLC on Mar 28, 2018 and is designated Class II. Reason for recall: products may be missing a one-way valve on the fluid patient port. The recall status is terminated (terminated Nov 29, 2018). Affected quantity: 3600 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 9, 2018
- Initiation Date
- Mar 28, 2018
- Termination Date
- Nov 29, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3600 units
Product Description
Medi-Vac(TM) Flex Advantage(TM) Suction Canister Liner, Material Numbers: a) REF 6561-910C b) REF 6561-916K c) REF 6561-920C To remove blood and/or body fluids. These fluids may be suctioned during surgical procedures or other applications requiring the removal of built up fluids. The suction canisters are used in operating rooms but are also used outside the surgical field as well as post-operatively within patient suites. The collection containers hold the fluids until they are ready for proper disposal. Sources of vacuum range from wall suction (central vacuum piped throughout the healthcare facility) to liposuction devices (portable suction pumps).
Reason for Recall
products may be missing a one-way valve on the fluid patient port.
Distribution Pattern
US Distribution to the state of MA
Code Information
a) REF 6561-910C, Lot Numbers: J802-384, J802-391 b) REF 6561-916K, Lot Number: J802-386 c) REF 6561-920C, Lot Number: J802-396
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1546-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026