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Catheter Set, 190mm Cut-to Size (36" tube), 9" Introducer

Ambu A/S · Model 418000535 · UDI-DI 05707480110872

MEB Prescription

510(k) clearances

33,522

Adverse events (59 deaths)

109

Recalls

Facilities

Description

Catheter set (190mm cut-to size, 920mm tubing + 9" introducer+Dressings), stand alone, complementary accessory (to be used with ACTion Block and ACTion Fuser ONLY)

Recalls

Date	Firm	Reason
2019-05-23	Leventon S. A. U.	The product lacks 510(k) clearance, and therefore is misbranded and must be removed from the U.S. market.
2018-10-02	Arrow International Inc	Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alte
2018-10-02	Arrow International Inc	Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alte
2018-10-02	Arrow International Inc	Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alte
2018-10-02	Arrow International Inc	Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alte
2018-10-02	Arrow International Inc	Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alte
2018-10-02	Arrow International Inc	Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alte
2018-10-02	Arrow International Inc	Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alte
2018-10-02	Arrow International Inc	Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alte
2018-10-02	Arrow International Inc	Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alte

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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.