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V. Mueller

STERIS CORPORATION · Model CH8051-1 · UDI-DI 10885403181573

GEA Prescription
10
510(k) clearances
1,037
Adverse events (1 deaths)
24
Recalls
377
Facilities

Description

V. Mueller SUCTION INSTRUMENT 5MM TB, YANK HDL, withVARI SUCT WORKING LENGTH 12.5 inches 32CM OVERALL LENGTH 17.75 inches 45.5CM

Recalls

DateFirmReason
2024-12-03Sklar InstrumentsReports of various packaging issues that may result in a breach of the sterile barrier.
2021-04-01CLINICAL LASERTHERMIA SYSTEMS ABsingle use devices labeled as sterile may not have been adequately sterilized
2020-01-15Cardinal Health 200, LLCNon-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "NON-STERILR" ; the product did not undergo sterilization process and is non-sterile
2019-07-16TeDan Surgical Innovations LLCThere was incorrect raw material used in the production of the identified lot.
2018-08-21Genicon, Inc.There is potential for the plastic optical tip to become detached from the metal shaft.
2018-08-21Genicon, Inc.There is potential for the plastic optical tip to become detached from the metal shaft.
2018-08-21Genicon, Inc.There is potential for the plastic optical tip to become detached from the metal shaft.
2018-08-21Genicon, Inc.There is potential for the plastic optical tip to become detached from the metal shaft.
2018-08-21Genicon, Inc.There is potential for the plastic optical tip to become detached from the metal shaft.
2018-08-21Genicon, Inc.There is potential for the plastic optical tip to become detached from the metal 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.