RecallRadar

FDA Device recall Z-1648-2021

10G COAXIAL CANNULA WITH TUOHY CONNECTION, CODE INTVM-CC

On 2021-05-26 the FDA classified a Class II recall of 10G COAXIAL CANNULA WITH TUOHY CONNECTION, CODE INTVM-CC by Biopsybell S R L, citing products labeled as sterile were distributed, but may not have been sterilized.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1648-2021
ClassificationClass II
Statusterminated
Initiated2021-03-22
Published2021-05-26
Last updated2026-09-13 11:56 UTC
CompanyBiopsybell S R L
DistributionUS

Product

10G COAXIAL CANNULA WITH TUOHY CONNECTION, CODE INTVM-CC

Reason

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

Identifiers

code_infoLOT: 20102495

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1648-2021%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.