Recalls / —
—#171198
Product
Kendall SCD Express Sterile Sleeves (Thigh Length), Model Number 9736
- FDA product code
- JOW — Sleeve, Limb, Compressible
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- 510(k) numbers
- K781357
- Affected lot / code info
- Lot Number 83410S09D
Why it was recalled
The product does not meet sterility requirements. Product labeled as sterile was distributed without undergoing sterilization prior to distribution.
Root cause (FDA determination)
Under Investigation by firm
Action the firm took
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.
Recalling firm
- Firm
- COVIDIEN LLC
- Address
- 15 Hampshire St, Mansfield, Massachusetts 02048-1113
Distribution
- Distribution pattern
- The products were distributed to the following US states: CA, NJ, and WA.
Timeline
- Recall initiated
- 2019-02-15
- Terminated
- 2020-07-24
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #171198. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.