Recall Z-1041-2019 ยท JOW Sleeve, Limb, Compressible
COVIDIEN LLC
Kendall SCD Express Sterile Sleeves (Thigh Length), Model Number 9736
| Date | Feb 15, 2019 |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K781357 | T.E.D. SEQUENTIAL COMPRESSION SLEEVES Kendall Research Center, Sep 20, 1978 |