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ELMED

ELMED INCORPORATED · Model EL-CH5669-001 · UDI-DI 00842180178717

GDG Prescription
10
510(k) clearances
277
Adverse events
7
Recalls
313
Facilities

Description

DeBakey vascular scissors. Blade length 1in (25mm). Mirror finish. Blades angled 25 degrees

Recalls

DateFirmReason
2024-12-03Sklar InstrumentsReports of various packaging issues that may result in a breach of the sterile barrier.
2024-11-12MEDLINE INDUSTRIES, LP - NorthfieldWeak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
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.
2011-12-06Teleflex MedicalTeleflex Medical received complaints that the elastic bands are breaking, cracking and /or deteriorating prior to their expiration date. If the elastic bands break during use there
2011-12-06Teleflex MedicalTeleflex Medical received complaints that the elastic bands are breaking, cracking and /or deteriorating prior to their expiration date. If the elastic bands break during use there
2008-05-12Telefelx MedicalThe bands are breaking within the sealed packaging or in use prior to the expiration dates.
2008-05-12Telefelx MedicalThe bands are breaking within the sealed packaging or in use prior to the expiration dates.

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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.