Recall Record

Mansfield, MA, United States

Medtronic Minimally Invasive Therapies Group recalls

2 recalls recorded since 2018, most recently on 24 October 2017. None are listed as ongoing. Status and classification are as published by the FDA.

Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0

Terminated Class II Medical devices

Recall started
24 October 2017
Terminated
26 October 2020
Reason
Incorrect packaging. In one lot of Argyle Suction Tubing, the pouch may be incorrectly labeled as the Salem Sump Dual Lumen Stomach Tube. This product may have been distributed within the case of Argyle Suction Tubing.
Distribution
USA (nationwide) Distribution
Initiated
Voluntary: Firm initiated
Recall number
Z-0936-2018

Terminated Class II Medical devices

Recall started
14 October 2017
Terminated
15 June 2018
Reason
Medtronic is voluntarily recalling one lot of its MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays, Lot 1717900160, following notification from our supplier that one production lot of MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays was inadvertently shipped to Medtronic and distributed without being sterilized.
Distribution
U.S.
Initiated
Voluntary: Firm initiated
Recall number
Z-1007-2018

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.