Z-2487-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 25, 2018
- Initiation Date
- June 11, 2018
- Termination Date
- August 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 Cassette, 5mm x 33cm Composite Probe, Double Spike, Ref ASC1201, 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 11742, 41742, 41746, 41752, 41751, 41761, 41762, 41753, 41763, 41765, 41754, 41756, 41759, 41755, 41757, and 41758.