Z-0936-2018Class II

Argyle Suction Tubing (Product # 8888301515) Argyle Suction Tubing is an extruded tube used as an extension...

Name: Z-0936-2018 Argyle Suction Tubing (Product # 8888301515) Argyle Suction Tubing is an extruded tube used as an extension...
Creator: Medtronic Minimally Invasive Therapies Group
Published: 2017-10-24
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2017-10-24 / Terminated / root cause: packaging

FDA source

Medtronic Minimally Invasive Therapies Group began a recall of Argyle Suction Tubing (Product # 8888301515) Argyle Suction Tubing is an extruded tube used as an extension for different types of devices in an operating... on 2017-10-24. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0936-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-24
Posted: 2018-03-05
Terminated: 2020-10-26
Recalling firm: Medtronic, Inc.
Product: Argyle Suction Tubing (Product # 8888301515) Argyle Suction Tubing is an extruded tube used as an extension for different types of devices in an operating room, bonded with 2 female sure grip connectors at each end of the tube to facilitate the plug/ insertion of the device and also includes a male connector that can be used for devices designed with female connectors, This product is sterile, non-conductive and latex free.
Product code: GAZ Tubing, Noninvasive
Reason for recall: 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.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: An URGENT MEDICAL DEVICE RECALL letter was issued to customers on October 24, 2017. This letter notified customers of the products subject to the recall and stated the following: The primary package labeling (Label closest to the product) may be incorrect. Customers can identify the affected product by consulting Attachment B. Please quarantine and return any unused products of the item codes and lot detailed above. Unused products from the affected item code and lots should be returned as described in the Required Actions section below. If you have distributed the Argyle" Suction tubing listed above, please promptly forward the information from this letter to those recipients. All unused products from the affected item codes and lots must be returned. If you have any questions regarding this communication, please contact your Medtronic representative or Customer Service at 800-962-9888, option 2.
Quantity in commerce: 58,954
Distribution: USA (nationwide) Distribution
Product codes and lots: 710016864X

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0936-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0936-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-15

Product code GAZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)