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Detecto

CARDINAL SCALE MANUFACTURING COMPANY · Model AP-4KD · UDI-DI 00809161142709

FQA

510(k) clearances

Adverse events

Recalls

Facilities

Description

Diaper/Lap Sponge Scale, Digital, 4000 g x 1 g

Recalls

Date	Firm	Reason
2018-12-04	Stryker Instruments Div. of Stryker Corporation	Gauss Surgical is updating the Instructions for Use (IFU) for our Triton Sponge System in order to clarify proper technique for handling sponges and the calibration placard.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.