Cook Incorporated: Chiba Biopsy Needle - Used for aspiration biopsy. REFERENCE PART NUMBER (RPN) ORDER NUMBER (GPN): 1) DCHN-18-10.0 G01559 2) DCHN-18-10.0-U G05040 3) DCHN-18-15.0 G00850 4) DCHN-22-1

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: 6,178 units Lot/code info: RPN/UDI/Lot Numbers 1) DCHN-18-10.0 (01)00827002015593(17) 15787141, 15787142, 15787693, 15794668, 15794669, 15794728, 15797998 2) DCHN-18-10.0-U (01)00827002050402(17) NS15781793, NS15781794, NS15783895 NS15783896, NS15783899, NS15783900, NS15784336, NS1580853,5 NS15808536, NS15808537 3) DCHN-18-15.0 (01)00827002008502(17) 15595244 4) DCHN-22-10.0 (01)00827002008526(17) 15628472 5) DCHN-22-10.0-U (01)00827002039780(17) 15614507 6) DCHN-22-15.0 (01)00827002000124(17) 15628470, 15785990,15791249 15794719 7) DCHN-22-15.0-U (01)00827002033146(17)15784638, 15784722,15784724, 15795935, 15797991, 15797992 8) DCHN-22-20.0 (01)00827002000131(17) 15629865 9) DCHN-22-20.0-U (01)00827002043381(17) NS15808547

UPC codes

00827002015593, 00827002050402, 00827002008502, 00827002008526, 00827002039780, 00827002000124, 00827002033146, 00827002000131, 00827002043381

Source

Official record: FDA (Device enforcement) ↗

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