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V. Mueller

STERIS CORPORATION · Model CH2438 · UDI-DI 10885403025440

MDM Prescription
10
510(k) clearances
4,164
Adverse events (4 deaths)
76
Recalls
846
Facilities

Description

V. Mueller VITAL MAYO HEGAR NDL HOLDER STR, TUNGSTEN CARBIDE INSERTS DOUBLE ACTION BOX LOCKS OVERALL LENGTH 18 inches 45.7CM

Recalls

DateFirmReason
2025-03-03MEDLINE INDUSTRIES, LP - NorthfieldThere is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
2024-12-03Sklar InstrumentsReports of various packaging issues that may result in a breach of the sterile barrier.
2024-02-23MEDLINE INDUSTRIES, LP - NorthfieldProduct may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
2024-01-31Technicality Inc.The Ring on the Trump Needle Guide can detach when excessive pressure is applied.
2024-01-30Applied Medical Resources CorpTheir is the potential that Universal Clip applier may not load clip after the trigger is actuated.
2024-01-30Applied Medical Resources CorpTheir is the potential that Universal Clip applier may not load clip after the trigger is actuated.
2022-11-17MEDLINE INDUSTRIES, LP - NorthfieldSterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
2022-11-08ENDO Pharmaceuticals Solutions, Inc.No expiration dates printed on the packaging
2022-11-02Arthrex, Inc.The devices may be packaged with the wrong reamer size.
2021-12-22FlexDex Inc.The firm is reinforcing the IFU instructions: "Do not use if the package is damaged." If upon inspection of the packaging, any damage is observed, including pinholes or tears in th

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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.