Z-2488-2018 Class II Terminated
FDA device recall Z-2488-2018 was initiated by Cardinal Health 200, LLC on Jun 11, 2018 and is designated Class II. Reason for recall: The suction valve may not close properly which could cause continuous suction. The recall status is terminated (terminated Aug 17, 2020). Affected quantity: A total of 63,020 valves were distributed. Specific product quantities were not provided.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 25, 2018
- Initiation Date
- Jun 11, 2018
- Termination Date
- Aug 17, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- A total of 63,020 valves were distributed. Specific product quantities were not provided.
Product Description
Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Single Spike and no Probe, Ref ASC1220, packaged 1/box, 12 boxes/case, single use, RX, Sterile.
Reason for Recall
The suction valve may not close properly which could cause continuous suction.
Distribution Pattern
Distribution was made to AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MT, NC, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, and WY. Government and military distribution was also made. Foreign distribution was made to Belgium, France, Germany, Israel, Italy, Netherlands, Singapore, and United Kingdom.
Code Information
Lot numbers 41718,41770,41768,41769,81702, and 81708.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2488-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026