FDA recall Z-1452-2022

Stryker Instruments Div. of Stryker Corporation · Class II · device

Product

SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002-090. Used for counting, displaying, recording and locating the number of RFID-tagged absorbent articles used during surgical procedures.

Reason for recall

When scanning sponges out after a surgical procedure, an error may allow for a duplicate sponge to be counted without the prompt to make a case note and allowing the case to close. The software update will prevent the occurrence of this error.

Distribution

The products were distributed to the following US states: KS and ME.

Key facts

Status
Terminated
Initiation date
2022-06-15
Report date
2022-07-27
Termination date
2024-04-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Portage, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1452-2022