Cook Incorporated: Dilator With AQ Hydrophilic Coating - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applicat

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: 1,493 units Lot/code info: Ref. Number/UDI-DI/Lot Numbers: 1) JCD10.0-38-20-HC (01)00827002102071(17) 15794369 2) JCD14.0-38-20-HC (01)00827002102934(17) 15778297, 15787264 3) JCD16.0-38-20-HC (01)00827002102064(17) 15794375 4)JCD6.0-38-20-HC (01)00827002102859(17) NS15808469 5) JCD8.0-38-20-HC (01)00827002102897(17) 15761259

UPC codes

00827002102071, 00827002102934, 00827002102064, 00827002102859, 00827002102897

Source

Official record: FDA (Device enforcement) ↗

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