PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: July 25, 2018 Initiated: June 11, 2018 #Z-2487-2018

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.

Details

Recalling Firm
Cardinal Health 200, LLC
Units Affected
A total of 63,020 valves were distributed. Specific product quantities were not provided.
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.
Location
Waukegan, IL

Frequently Asked Questions

What product was recalled?
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.. Recalled by Cardinal Health 200, LLC. Units affected: A total of 63,020 valves were distributed. Specific product quantities were not provided..
Why was this product recalled?
The suction valve may not close properly which could cause continuous suction.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 25, 2018. Severity: Moderate. Recall number: Z-2487-2018.