FDA Device recall Z-1041-2019
Kendall SCD Express Sterile Sleeves (Thigh Length), Model Number 9736
- FDA Device
- Class II
- terminated
- Published 2019-04-03
On 2019-04-03 the FDA classified a Class II recall of Kendall SCD Express Sterile Sleeves (Thigh Length), Model Number 9736 by Covidien, citing the product does not meet sterility requirements. Product labeled as sterile was distributed without undergoing sterilization prior to distribution.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1041-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-02-15 |
| Published | 2019-04-03 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Covidien |
| Distribution | CA, NJ, WA |
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.
Identifiers
| code_info | Lot Number 83410S09D |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1041-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.