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.
FDA Recall Z-2487-2018 · Posted None
Recalling FirmCardinal Health 200, LLC
Recall StatusTerminated
Product CodeGBX
Date Initiated2018-06-11
Date Terminated2020-08-17
Product QuantityA total of 63,020 valves were distributed. Specific product quantities were not provided.
Reason for Recall
The suction valve may not close properly which could cause continuous suction.
Firm Action
The recalling firm issued letters dated 6/11/2018 via FedEx Next Day Priority Mail requesting return of the product.
Root Cause
Device Design
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.