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Open, Classified

Medtronic MiniMed(TM) Pro-set(TM) (MMT-280, 281)

FDA Recall Z-0111-2018 · Posted None

Recalling FirmMedtronic Inc.
Recall StatusOpen, Classified
Product CodeFPK
Date Initiated2017-09-10
Product Quantity5,842 units

Reason for Recall

Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin.

Firm Action

The firm initiated its recall on 09/11/2017 by issuing a public notice, following with letters and emails. The firm also employed the use of Facebook and Twitter as well as posting on its website. The recall notice directs the customer to visit https://checklots.medtronicdiabetes.com for information on the lot numbers. Persons with additional questions may call Medtronic at 1.888.204.7616.

Root Cause

Component design/selection

Distribution Pattern

Worldwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K160651BD FlowSmart Set, MiniMed Pro-SetBecton, Dickinson and Company · 2016-04-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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