FDA recall Z-1885-2020

Product

ACMI 9FR PROBE (E4-9F) Manufactured for Olympus Surgical Technologies, America (OSTA); NTI Catalog Number 72-00198-0 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.

Reason for recall

Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.

Distribution

US Nationwide distribution. No governmental.

Key facts

Status

Terminated

Initiation date

2020-03-10

Report date

2020-05-13

Termination date

2021-02-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Elgin, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1885-2020