Cook Incorporated: Dilator - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous,

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: 5,998 units Lot/code info: 1)JCD10.0-38-20 (01)00827002009936(17) Lot Numbers: 15794371, 15794373, 15794374, 15806068, 15816198, 15816199 15816200 2) JCD20.0-38-20 (01)00827002014718(17) Lot Numbers: 15784153, 15784159, 15784160, 15794192, 15794199, 15794202. 15804028 3) JCD22.0-38-20 (01)00827002014725(17) Lot Numbers: 15794207, 15806062 4) JCD6.0-38-15 (01)00827002009448(17) Lot Number: 15814407 5) JCD8.0-38-15 (01)00827002009998(17) Lot Numbers: 15797971, 15797979 6) JCD8.0-38-20 (01)00827002009806(17) Lot Number:15791073

UPC codes

00827002009936, 00827002014718, 00827002014725, 00827002009448, 00827002009998, 00827002009806

Source

Official record: FDA (Device enforcement) ↗

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