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Recall – UnoMedical – Tandem infusion Sets

By January 24, 2024Recalls

About the Recall:

Unomedical, manufacturer of Tandem infusion sets, has informed us of a voluntary recall involving VariSo infusion sets. As a valued distribu on partner of Tandem Diabetes Care, we ask that you promptly act as outlined below.
Description of problem:
Unomedical a/s has found that in rare cases the VariSoft infusion set connector detaches more easily from the infusion set than expected, requiring less force to disconnect than intended, and thereby interrupting the delivery of insulin.

Products(s) numbers/models that are affected:

Lot numbers affected: 5388367; 5388357; 5388371; 5388362; 5388368; 5388366; 5388372; 5388376

URL Link(s) to Manufacturer Notice/Web Site:

Actions to be taken by customer/Patient:

  1. Immediately review your inventory and isolate the affected lot numbers of VariSoft infusion sets. Work with your Tandem representative to exchange the affected inventory.
  2. Immediately email the attached Unomedical patient letter to your Tandem VariSoft infusion set customers.
  3. Email your Tandem representative the total number of customers that you have contacted for documentation.
  4. If contacted by a customer who has affected product, please have them reach out to Tandem Customer Technical Support by email or phone to process an exchange:Email: Techsupport@tandemdiabetes.com
    Phone: 1-877-801-690
Customers emailing or calling Tandem Customer Technical Support should provide the number of boxes being returned and the lot numbers associated with those boxes.