Medtronic Perfusion Systems: Medtronic Left Heart Vent Catheters: a) DLP¿ Intracardiac Sump 20 Fr, Model Number 12012, b) DLP¿ Left Heart Vent Catheter 10 Fr., Model Number 12008, c) DLP¿ Left Heart V

Hazard

Potential for unsealed sterile packing.

Details from the source

Reason for recall: Potential for unsealed sterile packing. Distribution: Worldwide distribution. Quantity: 13954 units Lot/code info: a) Model Number 12012, GTIN 20613994619246, Lot Numbers: 2023050080, 202306C144; b) Model Number 12008, GTIN 00643169880665, Lot Numbers: 2023040819; b) Model Number 12008, GTIN 00673978176307, Lot Numbers: 2023040819, 2023040820; b) Model Number 12008, GTIN 20643169880669, Lot Numbers: 2023040819, 2023040820, 202307C103; c) Model Number 12001, GTIN 00643169878686, Lot Numbers: 2023040810; c) Model Number 12001, GTIN 20643169878680, Lot Numbers: 2023040810, 2023040811, 202306C141; d) Model Number 12113, GTIN 20643169881338, Lot Numbers: 2023090675; e) Model Number 12016, GTIN 20613994540434, Lot Numbers: 2023050083, 202305C093; f) Model Number 12002, GTIN 20613994540465, Lot Numbers: 2023041178, 202305C079; g) Model Number 12220, GTIN 00613994540355, Lot Numbers: 2023041202, 2023050095; g) Model Number 12220, GTIN 20613994540359, Lot Numbers: 2023041202, 2023050095, 202305C096, 202306C159; h) Model Number 12010, GTIN 00673978176321, Lot Numbers: 2023041180, 2023041182, 2023041183, 2023041188, 2023041189, 2023050075; h) Model Number 12010, GTIN 20613994619215, Lot Numbers: 2023041180, 2023041181, 2023041182, 2023041183, 2023041184, 2023041188, 2023041189, 2023050075, 202305C086, 202305C087

UPC codes

20613994619246, 00643169880665, 00673978176307, 20643169880669, 00643169878686, 20643169878680, 20643169881338, 20613994540434, 20613994540465, 00613994540355, 20613994540359, 00673978176321, 20613994619215

Source

Official record: FDA (Device enforcement) ↗

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