| Class 2 Device Recall Hydroline Trumpet Valve, Ref ASU1201 | |
Date Initiated by Firm | June 11, 2018 |
Create Date | July 18, 2018 |
Recall Status1 |
Terminated 3 on August 17, 2020 |
Recall Number | Z-2491-2018 |
Recall Event ID |
80288 |
Product Classification |
Catheter, irrigation - Product Code GBX
|
Product | Hydroline Trumpet Valve, Trumpet Valve, 5mm x 33cm Probe, Double Spike, Ref ASU1201, packaged 1/box, 12 boxes/case, single use, RX, Sterile. |
Code Information |
Lot numbers 31712, 31711, 31713, 31714, 31764, 31765, 41711, 41713, 41715, 41724, 41737, 41714, 41721, 41722, 41723, 41727, 41726, 41725, 41719, 41731, 41732, 41730, 41728, 41733, 41734, 41735, 71738, 71739, 71740, 71748, 71741, 71742, 81745, and 71743. |
Recalling Firm/ Manufacturer |
Cardinal Health 200, LLC 3651 Birchwood Dr Waukegan IL 60085-8337
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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 |
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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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