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U.S. Department of Health and Human Services

Class 2 Device Recall Hydroline Trumpet Valve with Pulse Wave Cassette, Ref ASC 1200

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  Class 2 Device Recall Hydroline Trumpet Valve with Pulse Wave Cassette, Ref ASC 1200 see related information
Date Initiated by Firm June 11, 2018
Create Date July 18, 2018
Recall Status1 Terminated 3 on August 17, 2020
Recall Number Z-2486-2018
Recall Event ID 80288
Product Classification Catheter, irrigation - Product Code GBX
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.
Code Information Lot numbers 41742,41739,41740, and 41741.
Recalling Firm/
Manufacturer		 Cardinal Health 200, LLC
3651 Birchwood Dr
Waukegan IL 60085-8337
For Additional Information Contact Customer Advocacy
800-292-9332
Manufacturer Reason
for Recall		 The suction valve may not close properly which could cause continuous suction.
FDA Determined
Cause 2		 Device Design
Action The recalling firm issued letters dated 6/11/2018 via FedEx Next Day Priority Mail requesting return of the product.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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