Medical device recalls Moderate risk

BIOPSYBELL S.R.L. recalls 10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES, CODE INTVM-SCDK

Recall date
March 22, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1646-2021
FDA classification
Class II
Brand / firm
BIOPSYBELL S.R.L.
Sold / distributed
US Nationwide distribution in the states MS and KY.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES, CODE INTVM-SCDK

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