Z-0597-2019Class II

Salem Sump Dual Lumen Stomach Tube 10 Fr/Ch (3.3 mm) x 36" (91 cm), Product Code 8888264911

Name: Z-0597-2019 Salem Sump Dual Lumen Stomach Tube 10 Fr/Ch (3.3 mm) x 36" (91 cm), Product Code 8888264911
Creator: Covidien Llc
Published: 2018-10-31
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2018-10-31 / Terminated / root cause: packaging

FDA source

COVIDIEN LLC began a recall of Salem Sump Dual Lumen Stomach Tube 10 Fr/Ch (3.3 mm) x 36" (91 cm), Product Code 8888264911 Product Usage: The Salem Sump Tubes are intended for decompression... on 2018-10-31. FDA classified it as Class II and gives the reason as "This voluntary recall is being conducted due to incorrect packaging. In one lot of Salem Sump Dual Lumen Stomach Tubes the 10Fr product was packaged in a 16Fr pouch. The use of a 10 Fr Salem Sump Tube when a 16Fr is...". 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-0597-2019
Classification: Class II
Status: Terminated
Initiated: 2018-10-31
Posted: 2018-12-11
Terminated: 2020-05-26
Recalling firm: Medtronic, Inc.
Product: Salem Sump Dual Lumen Stomach Tube 10 Fr/Ch (3.3 mm) x 36" (91 cm), Product Code 8888264911 Product Usage: The Salem Sump Tubes are intended for decompression and drainage of stomach contents following injury, illness, or surgery in patients with intestinal obstruction, and to prevent the distention of the stomach.
Product code: KNT Tubes, Gastrointestinal (And Accessories)
Reason for recall: This voluntary recall is being conducted due to incorrect packaging. In one lot of Salem Sump Dual Lumen Stomach Tubes the 10Fr product was packaged in a 16Fr pouch. The use of a 10 Fr Salem Sump Tube when a 16Fr is needed could result in decreased fluid collection, with the potential to affect patient care, particularly in an emergency situation where the correct size is not readily available.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: On October 31, 2018, the firm distributed Urgent Medical Device Recall letters to affected customers. Customers were informed of the incorrect packaging issue. Action Required: 1. INSPECT your inventory for the affected product code and lot number (listed on package) 2. SEGREGATE and QUARANTINE all on-hand product 3. RETURN the enclosed acknowledgment form via fax to 847-689-9101 or 614-652-9648, whether or not you have affected product, indicating the product code, lot and quantity of product youve quarantined or discarded. 4. NOTIFY any customers to whom you may have distributed, or forwarded product affected by this recall 5. CONTACT the appropriate Customer Service group to arrange for return and credit of any affected product: Hospital800-964-5227 Federal Government800-444-1166 Distributor800-635-6021 All other customers888-444-54401
Quantity in commerce: 1522
Distribution: Worldwide Distribution - US Nationwide and foreign distribution to Canada.
Product codes and lots: 1812115564

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0597-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0597-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-19	2018-12-11

Product code KNT

K810156Class IIArgyle Salem Sump TubeSherwood Medical Co. / cleared 1981-03-02

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)