FDA recall Z-2463-2023

Stryker Corporation · Class II · device

Product

SurgiCount+ Software Application-indicated as an adjunctive technology for augmenting the manual process of counting, displaying and recording the number of RFID-tagged absorbent articles used during surgical procedures Product Code: 0694-002-090;

Reason for recall

Potential for current software to miscount when scanning in multiple sponge-products from the same unique sponge-pack type

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2023-07-10
Report date
2023-09-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Portage, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2463-2023