Product Wiki · Recalls · U.S. FDA — Device Enforcement

10G DIRECT SINGLE - ACCESS, CODE INTVM-DSBAK — recall Z-1639-2021

U.S. FDA — Device Enforcement · Italy · 2021-03-22 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1639-2021
Date of alert
2021-03-22
Country / jurisdiction
Italy
Risk level
Class II
Risk type
recall
Brand
BIOPSYBELL S.R.L.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
20051288
Reported risk: Products labeled as sterile were distributed, but may not have been sterilized.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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