PlainRecalls
FDA Devices Moderate Class II Completed

11G DIRECT SINGLE - DELIVERY (4 FILLERS-4 SYRINGES), CODE INTVMN-SCDK

Reported: May 26, 2021 Initiated: March 22, 2021 #Z-1641-2021

Product Description

11G DIRECT SINGLE - DELIVERY (4 FILLERS-4 SYRINGES), CODE INTVMN-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
160 units
Distribution
US Nationwide distribution in the states MS and KY.
Location
Mirandola, N/A

Frequently Asked Questions

What product was recalled?
11G DIRECT SINGLE - DELIVERY (4 FILLERS-4 SYRINGES), CODE INTVMN-SCDK. Recalled by BIOPSYBELL S.R.L.. Units affected: 160 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-1641-2021.