RecallDepth

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.

This recall has been terminated (originally issued June 11, 2018).

Company
Cardinal Health 200, Llc
Recall Initiated
June 11, 2018
Terminated
August 17, 2020
Recall Number
Z-2485-2018
Quantity
A total of 63,020 valves were distributed. Specific product quantities were not provided.
Firm Location
Waukegan, IL
Official Source
View on FDA website ↗

Reason for Recall

The suction valve may not close properly which could cause continuous suction.

Distribution

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.

Lot / Code Info

Lot numbers 41717 and 71734.

Root Cause

Device Design

Action Taken

The recalling firm issued letters dated 6/11/2018 via FedEx Next Day Priority Mail requesting return of the product.

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