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U.S. Department of Health and Human Services

Class 2 Device Recall MEDRAD Stellant FLEX Syringe Kits

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  Class 2 Device Recall MEDRAD Stellant FLEX Syringe Kits see related information
Date Initiated by Firm October 05, 2020
Create Date November 23, 2020
Recall Status1 Terminated 3 on March 19, 2021
Recall Number Z-0483-2021
Recall Event ID 86619
510(K)Number K192370  
Product Classification Injector and syringe, angiographic - Product Code DXT
Product Brand Name: MEDRAD Stellant FLEX Syringe Kits

Common Name: Angiographic Syringe

Catalog/REF Number: FLEXD-150-SCS
Description: 2 - 150 mL FLEX syringes, 1 large saline spike, 1 small contrast spike, patient t-connector tubing & prime tube.

Catalog/REF Number: FLEXD-150-SPK
Description: 2 - 150 mL FLEX syringes, 2 small spikes, patient t-connector tubing & prime tube.
Code Information Catalog/REF Number: FLEXD-150-SCS  Material Number: 87078817  Lot Numbers: 8584324, 8586383, 8586384, 8586385,   8586386, 8586388   UDI Numbers:   (01)00616258022888(11)200620(17)240620(10)8584324  (01)00616258022888(11)200620(17)240620(10)8584324  (01)00616258022888(11)200620(17)240620(10)8584324  (01)00616258022888(11)200620(17)240620(10)8584324  (01)00616258022888(11)200620(17)240620(10)8584324  (01)00616258022888(11)200620(17)240620(10)8584324  Catalog/REF Number: FLEXD-150-SPK Material Number: 85020218 Lot Number: 8585234  UDI Numbers: (01)00616258010656(11)200720(17)240720(10)8585234 
Recalling Firm/
Manufacturer		 Bayer Medical Care, Inc.
1 Bayer Dr
Indianola PA 15051-9702
For Additional Information Contact Julia Mitchell
724-940-7890
Manufacturer Reason
for Recall		 Specific lots of MEDRAD Stellant FLEX 150 mL syringe kits may have holes and/or cracks that have the potential to allow fluid to leak out of the syringe.
FDA Determined
Cause 2		 Process control
Action On 10/08/020, Bayer sent all of their affected customers an Urgent Medical Device Field Corrective Action (recall) letter via e-mail. The recall letter requested that all of the affected customers immediately take the following steps: 1. Review your current inventory. Quarantine any affected batch/lot numbers referenced in the below chart. Instructions are included in this letter on how to identify batch/lot. 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. If product is needed immediately to avoid a stock out, expedited shipping options will be available. For expedited shipping options, please contact the Customer Logistics team at 724-940-7890. 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 the RGA number. 5. Upon Bayer receipt of return product, you will receive a credit on your account. Please distribute this letter to other appropriate departments and personnel within your institution who may have inventory that may be affected by this field corrective action.
Quantity in Commerce 92,420 units
Distribution Distributed to healthcare facilities nationwide throughout the US.
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.
510(K) Database 510(K)s with Product Code = DXT and Original Applicant = Bayer Medical Care, Inc.
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