FDA-Device2026-05-20Class IIPACKAGING DEFECT

Daig Livewire Steerable, Product Number 401582; REPROCESSED ELECTROPHYSIOLOGY CATHETER

OTHERNationwide distributiondevice
Hazard

Incomplete seals on sterile product

Who it affects
Adults
Illnesses reported
None reported
Sold states
US Nationwide and the countries of Israel and Canada.
Affected count
19 units
Manufactured in
1810 W Drake Dr, Tempe, AZ, United States
Products
Daig Livewire Steerable, Product Number 401582; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2188-2026

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