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Terminated

Kendall SCD Express Sterile Sleeves (Thigh Length), Model Number 9736

FDA Recall Z-1041-2019 · Posted None

Recalling FirmCOVIDIEN LLC
Recall StatusTerminated
Product CodeJOW
Date Initiated2019-02-15
Date Terminated2020-07-24
Product Quantity25 units

Reason for Recall

The product does not meet sterility requirements. Product labeled as sterile was distributed without undergoing sterilization prior to distribution.

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.

Root Cause

Under Investigation by firm

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K781357T.E.D. SEQUENTIAL COMPRESSION SLEEVESKendall Research Center · 1978-09-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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