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Welch Allyn, Inc.

WELCH ALLYN, INC. · Model 901075 · UDI-DI 00732094080629

KDM Prescription
1
510(k) clearances
0
Adverse events
1
Recalls
1
Facilities

Description

Welch Allyn 6.0 V Halogen Fiber-Optic Sigmoidoscope Set including Three Fiber-Optic Rigid Sigmoidoscopes with Obturators (#32410 15 mm x 15 cm, #32820 19 mm x 25 cm, #37023 23 mm x 7 cm), 30 cm Suction Tube (#30130), Insufflation Bulb (#30200), Fiber-Optic Light Head (#36019), Light Handle with 3.0 ft/0.9 m Cord (#73211), Power Transformer with 5.0

Recalls

DateFirmReason
2021-04-23Adler MicroMed, Inc.Due to issue with product sterility. Sterilization service provider had falsified records.

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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.