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FDA (Device enforcement)Recalled 2024-06-26class ii

Smiths Medical ASD Inc.: ENT RES, 100 ML, Non-Sterile W CLAMP & FEMALE LUER, Product Code 68-2231-28

Hazard

Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.

Details from the source

Reason for recall: Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage. Distribution: Worldwide distribution. Quantity: 120960 units Lot/code info: UDI/DI 30610586044186, Lot Numbers: 3997242-ENG, 4040002AB, 4040000AB, 4040001AB, 4040008AB, 4040007AB, 4040009AB, 4146021AB

UPC codes

30610586044186

Source

Official record: FDA (Device enforcement)

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

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