SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary bypass. Including the following components: a) 31 Fr ProtekDuo Veno-Venous Cannula Set b) LifeSPARC Pump c) 14Fr to 26 Fr Dilator Set d) TandemHeart Wrap. Kit Number: 5820-3118 Intended use is applicable to the intended use o
Check against the official notice below — it lists the full affected range.
Cardiac Assist, Inc. is recalling 7 units of its SHIP KIT collection kit (Item 5820-3118) used for temporary cardiopulmonary bypass procedures. The recall was issued because the side label of the outer package displayed an incorrect expiration date of 2021/05/01, while the top label correctly showed the actual expiration date of 2022/05/01. The affected units, identified by serial numbers 872170 through 872184, were distributed to medical facilities in Washington DC, Massachusetts, South Carolina, and Virginia.
The recall affects SHIP KIT packages containing a 31 Fr ProtekDuo Veno-Venous Cannula Set and LifeSPARC Pump. The product record does not specify what consumers or healthcare facilities should do in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Top label of the outer package of the collection kit Item 5820-3118 showed expiration date of 2022/05/01 (correct expiration date) while side label showed expiration date of 2021/05/01 (incorrect expiration date)
Reason for recall: Top label of the outer package of the collection kit Item 5820-3118 showed expiration date of 2022/05/01 (correct expiration date) while side label showed expiration date of 2021/05/01 (incorrect expiration date) Distribution: US Distribution to states of: DC, MA, SC, and VA. Quantity: 7 units Lot/code info: Serial Numbers: 872170, 872171, 872172, 872173, 872182, 872183, 872184. UDI: 01)00814112020791(17)220 501(22)220511(21) 872170; (01)00814112020791(17)220 501(22)220511(21) 872171; (01)00814112020791(17)220 501(22)220511(21) 872172; (01)00814112020791(17)220 501(22)220511(21) 872173; (01)00814112020791(17)220 501(22)220511(21) 872182; (01)00814112020791(17)220 501(22)220511(21) 872183; 01)00814112020791(17)220 501(22)220511(21) 872184
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.