Recall Z-1625-2016— Stryker Sustainability Solutions

Name: FDA recall Z-1625-2016
Creator: U.S. Food and Drug Administration
Published: 2016-04-04

Class II · Terminated

Class II FDA medical device recall by Stryker Sustainability Solutions, initiated 2016-04-04, terminated 2016-07-13. It names one FDA 510(k) clearance: K082520. Product: Mallinckrodt Evac Tracheal Tubes Model #124170-MALLINCKRODT & 124175. Reason: Device packaging may not be sealed..

Recalling firm: Stryker Sustainability Solutions
Classification: Class II
Status: Terminated
Initiated: 2016-04-04
Terminated: 2016-07-13
Firm location: Tempe, AZ, United States

510(k) clearances named in this recall

1 on FDA's record

K082520 — SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBESMallinckrodt Medical·cleared 2008-10-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Mallinckrodt Evac Tracheal Tubes Model #124170-MALLINCKRODT & 124175

Reason for recall

Device packaging may not be sealed.

Data sourced from openFDA. This site is unofficial and independent of the FDA.