Z-1041-2019Class II

Kendall SCD Express Sterile Sleeves (Thigh Length), Model Number 9736

Name: Z-1041-2019 Kendall SCD Express Sterile Sleeves (Thigh Length), Model Number 9736
Creator: Covidien Llc
Published: 2019-02-15
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2019-02-15 / Terminated / root cause: labeling and UDI

FDA source

COVIDIEN LLC began a recall of Kendall SCD Express Sterile Sleeves (Thigh Length), Model Number 9736 on 2019-02-15. FDA classified it as Class II and gives the reason as "The product does not meet sterility requirements. Product labeled as sterile was distributed without undergoing sterilization prior to distribution". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1041-2019
Classification: Class II
Status: Terminated
Initiated: 2019-02-15
Posted: 2019-03-22
Terminated: 2020-07-24
Recalling firm: Medtronic, Inc.
Product: Kendall SCD Express Sterile Sleeves (Thigh Length), Model Number 9736
Product code: JOW Sleeve, Limb, Compressible
Reason for recall: The product does not meet sterility requirements. Product labeled as sterile was distributed without undergoing sterilization prior to distribution.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Urgent Medical Device Recall notification letters dated 2/15/19 were sent to customers. An additional customer was identified and a letter was sent on 3/11/19.
Quantity in commerce: 25 units
Distribution: The products were distributed to the following US states: CA, NJ, and WA.
Product codes and lots: Lot Number 83410S09D

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1041-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1041-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-03	2019-03-22

Product code JOW

K781357Class IIT.e.d. Sequential Compression SleevesKendall Research Center / cleared 1978-09-20

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)