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U.S. Department of Health and Human Services

Class 2 Device Recall MEDRAD Twist & Go Disposable Syringe 150 mL with Quick Fill Tube

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 Class 2 Device Recall MEDRAD Twist & Go Disposable Syringe 150 mL with Quick Fill Tubesee related information
Date Initiated by FirmSeptember 14, 2021
Create DateNovember 03, 2021
Recall Status1 Terminated 3 on January 19, 2023
Recall NumberZ-0199-2022
Recall Event ID 88807
510(K)NumberK132928 
Product Classification Injector and syringe, angiographic - Product Code DXT
ProductThe MEDRAD Twist & Go Disposable Syringe 150 mL with Quick Fill Tube is a syringe made from a clear polycarbonate material and is an accessory to the MEDRAD Mark 7 Arterion Injection System. It is designed to be loaded into the injector head of the injection system.
Code Information Batch number: 8415317
Recalling Firm/
Manufacturer		 Bayer Medical Care, Inc.
1 Bayer Dr
Indianola PA 15051-9702
For Additional Information ContactSAME
412-406-3305
Manufacturer Reason
for Recall		Labeling error: MEDRAD Mark 7 Arterion Injection System Syringes (ART 700 SYR) labeled as Twist & Go Syringes (TAG 150 SYR)
FDA Determined
Cause 2		Packaging process control
ActionBayer issued Urgent Medical Device Recall Letter (Recall ID: SA-21-RAD-02) dated 9/14/21 via email. Letter states reason for recall, health risk and action to take: Review your current inventory for affected Lot 8415317 and quarantine, as appropriate. 2. Complete the included response form and submit through email to CLSCRiCustomerLogistics@bayer.com or contact the Customer Logistics team at 724-940-7890. Please complete the Customer Response Form regardless of whether you have affected product or not. This action will assist us in tracking all affected product. 3. You will receive a Return Goods Authorization (RGA) number to return any affected Syringe kits remaining in your inventory for a credit. We can send new syringe kits with a separate purchase order, as necessary. 4. Place the affected product in a box and label the outside of the container with the RGA number in large, bold writing. Use the shipping label provided via email when you receive your RGA number. Please return affected product no later than November 30, 2021. 5. Upon Bayer receipt of returned product, you will receive a credit on your account. Please distribute this letter to other appropriate departments and personnel within your facility who may need to maintain awareness of this recall.
Quantity in Commerce6,950 units
DistributionWorldwide distribution - US Nationwide and the countries of AU, BY, DE, DK, GB, HR, NL, NZ, RU, SE, TH.
Total Product Life CycleTPLC 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.
510(K) Database510(K)s with Product Code = DXT
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