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Recall Observatory FDA recall evidence

Device product

10 GAUGE CEMENT DELIVERY CANNULA, CODE INTVM-CDC

Z-1638-2021

March 22, 2021

Class II

Product summary

Firm
BIOPSYBELL S.R.L.
Event
Event 87696
Status
Terminated
Classification
Class II
Quantity
250 units
Official record key
device-enforcement:Z-1638-2021

Official wording

Reason: Products labeled as sterile were distributed, but may not have been sterilized.

Code information: LOT: 19112827, 2002440

Distribution pattern: US Nationwide distribution in the states MS and KY.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Products labeled as sterile were distributed, but may not have been sterilized.