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Recall Observatory FDA recall evidence

Device product

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.

Z-2488-2018

June 11, 2018

Class II

Product summary

Firm
Cardinal Health 200, LLC
Event
Event 80288
Status
Terminated
Classification
Class II
Quantity
A total of 63,020 valves were distributed. Specific product quantities were not provided.
Official record key
device-enforcement:Z-2488-2018

Official wording

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

Code information: Lot numbers 41718,41770,41768,41769,81702, and 81708.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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