Company: Stryker Corporation
Date of Enforcement Report: 08/25/2023
Class II
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.
Recall Number:
Z-2463-2023
REASON:
Potential for current software to miscount when scanning in multiple sponge-products from the same unique sponge-pack type.
RECALLING FIRM/MANUFACTURER:
Stryker Corporation
VOLUME OF PRODUCT IN COMMERCE:
57 units
DISTRIBUTION:
US Nationwide distribution.
