FDA Medical Device Recalls (openFDA)
COVIDIEN LLC: Kendall SCD Express Sterile Sleeves (Thigh Length), Model Number 9736
- Recall number
- Z-1041-2019
- Recalling firm
- COVIDIEN LLC
- Product
- Kendall SCD Express Sterile Sleeves (Thigh Length), Model Number 9736
- Status
- Terminated
- Initiated
- 2019-02-15
- Posted
- not on file
- Terminated
- 2020-07-24
- Reason
- The product does not meet sterility requirements. Product labeled as sterile was distributed without undergoing sterilization prior to distribution.
- 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
- 25 units
- Distribution
- The products were distributed to the following US states: CA, NJ, and WA.
- Lot, serial or model codes
- Lot Number 83410S09D
- 510(k) numbers
- ["K781357"]
- PMA numbers
- not on file
- Product code
- JOW
- Firm FEI
- 1282497
- Firm city
- Mansfield
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28