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Terminated

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.

FDA Recall Z-2488-2018 · 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.

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