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
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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
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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 |
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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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510(K) Database | 510(K)s with Product Code = DXT
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