Recall StatusTerminated
Date Initiated2020-07-06
Date Terminated2023-08-31
Product Quantity7401 units
Reason for Recall
Breaking at the point of a welded joint
Firm Action
Teleflex issued an Urgent Medical Device Recall on 07/06/2020. It states the following:
1. Immediately discontinue distribution and quarantine any products with the product code and lot number listed.
2. Using the provided customer letter and recall acknowledgement form templates, communicate this recall to any of your customers who have received product included within the scope of the recall.
3. Have the customers return any affected product to you, together with a completed Recall Acknowledgement Form, for consolidation and return to Teleflex Medical. In the event that an alternative approach is needed, contact Teleflex Medical Customer Service for more information at 1-866-396-2111.
4. To return recalled products to Teleflex Medical, complete the enclosed Recall
Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to
[email protected]. This will allow the firm to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of product to Teleflex Medical.
5. Once you have completed returning all of the recalled products from your own inventory, and collecting and consolidating all of the recalled products from your customers, please check the box on the enclosed Recall Acknowledgment Form that indicates that you have completed the recall and fax it to 1-855-419-8507, Attn: Customer Service, or email it to
[email protected]. This will allow to document completion of the recall.
6. If you and your customers have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to
[email protected]. This will allow to document your receipt of this letter.
If you have any other questions,contact your local sales representative or Customer Service at 1-866-396-2111.
Root Cause
Process control
Distribution Pattern
US Nationwide distribution including in the states of FL, KY, CA, ND, UT, MA, MD, AZ, MS, TX, MI, WV, AL, MO, SC, VA, AR, PA, OK, NV, NM, NE, IN, IA, NY, GA, NJ, MN, IL, NC, NH, TN, ID, CO, HI, MT, OR, ME, CT, LA, OH, RI, SD, WA, DC, KS, AK.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.