Sklar Instruments: ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE YANKAUER SUCTION TUBE 8.5" C10, Model Number 96-4176; 2) ECONO STERILE YANKAUER SUCTION TUBE 11" CS10, Model Number

Hazard

Reports of various packaging issues that may result in a breach of the sterile barrier.

Details from the source

Reason for recall: Reports of various packaging issues that may result in a breach of the sterile barrier. Distribution: Domestic: Nationwide Distribution Quantity: 150 units Lot/code info: 1) 96-4176, UDI/DI 50649111493674, Lot codes: FSS4, FSS5; 2) 96-4177, UDI/DI 50649111493681, Lot codes: FSS4, FSS5; 3) 96-5434, UDI/DI 50649111493612, Lot codes: FSS4, FSS5; 4) 96-5435, UDI/DI 50649111493629, Lot codes: FSS4, FSS5, FSS6; 5) 96-5436, UDI/DI 50649111493636, Lot codes: FSS4, FSS5; 6) 96-5437, UDI/DI 50649111493643, Lot codes: FSS4, FSS5; 7) 96-5438, UDI/DI 50649111493650, Lot codes: FSS4, FSS5; 8) 96-5439, UDI/DI 50649111493667, Lot codes: FSS4, FSS5; 9) 96-5440, UDI/DI 50649111493964, Lot codes: FSS4, FSS5; 10) 96-5492, UDI/DI 50649111481657, Lot codes: FSS4, FSS5; 11) 96-5493, UDI/DI 50649111481664, Lot codes: FSS4, FSS5; 12) 96-5494, UDI/DI 50649111481671, Lot codes: FSS4, FSS5.

UPC codes

50649111493674, 50649111493681, 50649111493612, 50649111493629, 50649111493636, 50649111493643, 50649111493650, 50649111493667, 50649111493964, 50649111481657, 50649111481664, 50649111481671

Source

Official record: FDA (Device enforcement) ↗

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