device · product 1 of 11
Hydroline Trumpet Valve with Pulse Wave Cassette, Cassette Trumpet Valve with Bariatric Probe, Double Spike, Ref ABP1201, packaged 1/box, 12 boxes/case, single use, RX, Sterile.
- Recall number
- Z-2485-2018
- Initiated
- June 11, 2018
- Classification
- Class II
- Status
- Terminated
- Recalling firm
- Cardinal Health 200, LLC
- Quantity
- A total of 63,020 valves were distributed. Specific product quantities were not provided.
App-derived interpretation
The suction valve may not close properly which could cause continuous suction.
Official device-enrichment evidence · Sourced
Device Design
Inspect official wording and provenance
Reason for recall
The suction valve may not close properly which could cause continuous suction.
Code information
Lot numbers 41717 and 71734.
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.