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ASSI

ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION · Model ASSI.B188TCC · UDI-DI 00841645110286

KOH
10
510(k) clearances
96
Adverse events
2
Recalls
83
Facilities

Description

Needle Holder, 18cm, Rnd Hdl, 8mm dia. Curved, 0.6mm Dia. TCC Jaw, W/Out Lock

Recalls

DateFirmReason
2021-04-15Boston Scientific CorporationPotential for pinholes (sterile barrier breach) on the edge of the pouch to potentially render the device non-sterile, and may result in a post-operative infection
2003-02-20Portex, IncMay have incorrectly printed graduation markings along the tube shaft.

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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.