FDA-Device2021-02-17Class II
PBD-203-0703 BILIARY STENT, model no. PBD-203-0703 - Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage.
Aomori Olympus Co., Ltd.
Hazard
Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
Sold states
US Nationwide distribution.
Affected count
7,400,000 (globally); 260,395 (US)
Manufactured in
2 Chome 248-1, Okkonoki, Kuroishi, N/A, Japan
Products
PBD-203-0703 BILIARY STENT, model no. PBD-203-0703 - Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1063-2021Don't want to check this manually?
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