Cook Incorporated: Dilator - Coons Taper - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, a

Hazard

Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility

Details from the source

Reason for recall: Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility Distribution: Worldwide distribution - US Nationwide and the countries of AT, AU, BR, CA, CH, DE, ES, GB, HK, IE, IL, IN, IT, NZ, SG. Quantity: 4,856 units Lot/code info: Ref. Number/UDI-DI/Lot Numbers: 1) JCD10.0-38-20- COONS (01)00827002039285(17) 15787236; 2) JCD12.0-38-20- COONS (01)00827002039292(17) 15774752, 15774753; 3) JCD14.0-38-20- COONS (01)00827002039322(17) 15797981, 15784149, 15797975 15797976, 15797982; 4) JCD16.0-38-20- COONS (01)00827002039476(17) 15794190, 15794191, 15808405; 5) JCD18.0-38-20- COONS (01)00827002040519(17) 15794189, 15797973; 6) JCD20.0-38-20- COONS (01)00827002042643(17) 15784152, 15784156, 15784158 15784164, 15794195, 15804033; 7) JCD 38-20- COONS (01)00827002044432(17) 15767086, 15784163, 15794203, 15806060; 8) JCD6.0-38-20- COONS (01)00827002042216(17) 15787237, 15787244 9) JCD8.0-38-20- COONS (01)00827002039278(17) 15797985, 15797999, 15798003

UPC codes

00827002039285, 00827002039292, 00827002039322, 00827002039476, 00827002040519, 00827002042643, 00827002044432, 00827002042216, 00827002039278

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.