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BlueBoost(TM) Submucosal Injectable Solution

Micro-Tech (Nanjing) Co., Ltd. · Model SML10 · UDI-DI 06932503562522

PLL Prescription
1
510(k) clearances
70
Adverse events
1
Recalls
13
Facilities

Description

Product is sky-blue viscous liquid, the content is 10ml. Initial packaging is the syringe.

Recalls

DateFirmReason
2022-10-10Boston Scientific Corporation***Update12/13/22***:Product removal due to higher incidence of adverse events of foreign body reactions*** Potential outcomes associated with foreign body reaction to remnant ORl

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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.