Smiths Medical ASD Inc.: smiths medical portex, 15mm Double Swivel Connector: a) REF 100/255/150; b) REF 100/255/150JP; c) REF 100/255/150 JS

Hazard

Uncertainty in the seal integrity of the sterile packaging.

Details from the source

Reason for recall: Uncertainty in the seal integrity of the sterile packaging. Distribution: Worldwide distribution. Quantity: 34,141 units Lot/code info: a) REF 100/255/150, UDI/DI 35019315022399, Lot Numbers: 4125006; UDI/DI 35019315010990, Lot Numbers: 4159808, 4161750; UDI/DI 35019315011003, Lot Numbers: 4131840; UDI/DI 35019315018156, Lot Numbers: 4131559; UDI/DI 35019315022405, Lot Numbers: 4122011, 4127688; b) REF 100/255/150JP, UDI/DI 35019315010990, Lot Numbers: 4089148, 4107293, 4122008, 4147817, 4138707, 4159808; c) REF 100/255/150 JS, UDI/DI 35019315010990, Lot Numbers: 4122008, 4147817, 4159808

UPC codes

35019315022399, 35019315010990, 35019315011003, 35019315018156, 35019315022405

Source

Official record: FDA (Device enforcement) ↗

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