Recall Z-1041-2019— COVIDIEN LLC

Name: FDA recall Z-1041-2019
Creator: U.S. Food and Drug Administration
Published: 2019-02-15

Class II · Terminated

Class II FDA medical device recall by COVIDIEN LLC, initiated 2019-02-15, terminated 2020-07-24. It names one FDA 510(k) clearance: K781357. Product: Kendall SCD Express Sterile Sleeves (Thigh Length), Model Number 9736. Reason: The product does not meet sterility requirements. Product labeled as sterile was distributed without undergoing sterilization prior to distribution..

Recalling firm: COVIDIEN LLC
Classification: Class II
Status: Terminated
Initiated: 2019-02-15
Terminated: 2020-07-24
Firm location: Mansfield, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K781357 — T.E.D. SEQUENTIAL COMPRESSION SLEEVESKendall Research Center·cleared 1978-09-20

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

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

Reason for recall

The product does not meet sterility requirements. Product labeled as sterile was distributed without undergoing sterilization prior to distribution.

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