PlainRecalls
FDA Devices Moderate Class II Completed

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

Reported: May 26, 2021 Initiated: March 22, 2021 #Z-1646-2021

Product Description

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

Reason for Recall

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

Details

Recalling Firm
BIOPSYBELL S.R.L.
Units Affected
305 units
Distribution
US Nationwide distribution in the states MS and KY.
Location
Mirandola, N/A

Frequently Asked Questions

What product was recalled?
10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES, CODE INTVM-SCDK. Recalled by BIOPSYBELL S.R.L.. Units affected: 305 units.
Why was this product recalled?
Products labeled as sterile were distributed, but may not have been sterilized.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 26, 2021. Severity: Moderate. Recall number: Z-1646-2021.