Recall Z-2486-2018— Cardinal Health 200, LLC
Class II · Terminated
Class II FDA medical device recall by Cardinal Health 200, LLC, initiated 2018-06-11, terminated 2020-08-17. FDA's recall record names no specific 510(k) clearance for this event. Product: Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Cassette, 5mm x 33cm Composite Probe, Single Spike, Ref ASC1200, packaged 1/box, 12 boxes/case, single use, RX, Sterile.. Reason: The suction valve may not close properly which could cause continuous suction..
- Recalling firm
- Cardinal Health 200, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-06-11
- Terminated
- 2020-08-17
- Firm location
- Waukegan, IL, United States
Product description
Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Cassette, 5mm x 33cm Composite Probe, Single Spike, Ref ASC1200, 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.