Z-1625-2016Class II

Mallinckrodt Evac Tracheal Tubes Model #124170-MALLINCKRODT & 124175

Name: Z-1625-2016 Mallinckrodt Evac Tracheal Tubes Model #124170-MALLINCKRODT & 124175
Creator: Stryker Sustainability Solutions
Published: 2016-04-04
License: https://open.fda.gov/license/

Stryker Sustainability Solutions / initiated 2016-04-04 / Terminated / root cause: manufacturing process

FDA source

Stryker Sustainability Solutions began a recall of Mallinckrodt Evac Tracheal Tubes Model #124170-MALLINCKRODT & 124175 on 2016-04-04. FDA classified it as Class II and gives the reason as "Device packaging may not be sealed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1625-2016
Classification: Class II
Status: Terminated
Initiated: 2016-04-04
Posted: 2016-05-09
Terminated: 2016-07-13
Recalling firm: Stryker Sustainability Solutions
Product: Mallinckrodt Evac Tracheal Tubes Model #124170-MALLINCKRODT & 124175
Product code: BTR Tube, Tracheal (W/Wo Connector)
Reason for recall: Device packaging may not be sealed.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Customer notification letter was sent 04/04/2016. The customer was provided the following instructions: Use of the affected lots of the recalled product should be discontinued. A Recall Effectiveness Check Form has been enclosed. Note that the recall is limited to the specific lot number shipped to facility. Once inventory has been checked complete the Recall Effectiveness Check Form. The form needs to be completed even if no affected product is found. Return the completed and signed Recall Effectiveness Check Form utilizing one of the following methods: Return to your local Stryker Sustainability Sales Representative Email to [email protected], or Mail to: Stryker Sustainability Solutions 181 O West Drake Drive Tempe, AZ. 85283 Attn: Jodie Rueckert If the form indicates that any affected devices remain in inventory, a prepaid shipping label will be issued for the return of the product. Customers will receive a credit for all affected devices returned. Adverse reactions or quality problems experienced with the use of this product may be reported to: Stryker Sustainability Solutions Complaint Hotline: +1(888) 888-3433x5555 http://www.stryker.com/productexperience/ The FDA's MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.
Quantity in commerce: 4
Distribution: US distribution to KY.
Product codes and lots: Lot #481938U

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1625-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1625-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-18	2016-05-09
Z-1626-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-18	2016-05-09

Product code BTR

K082520Class IISealguard Evac Endotracheal and Endotracheal TubesMallinckrodt Medical / cleared 2008-10-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)