FDA recall Z-1041-2019

COVIDIEN LLC · Class II · device

Product

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.

Distribution

The products were distributed to the following US states: CA, NJ, and WA.

Key facts

Status
Terminated
Initiation date
2019-02-15
Report date
2019-04-03
Termination date
2020-07-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Mansfield, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1041-2019