Official recall record

Mic* Gastric-Jejunal Feeding Tube With Enfit Connectors (Endoscopic/Radiologic Placement Kit)

What the authority reported

Avanos Medical Inc. is voluntarily recalling specific lots of Mic gastric - jejunal feeding tube kits. These kits contain a syringe prefilled with sterile water which is used to inflate the retention balloon of the feeding tube. Avanos has learned that the manufacturer of these pre-filled syringes, Nurse Assist, LLC, is recalling the syringes along with other pre-filled sterile water products. The reason for this recall is that they have determined that the water inside these devices cannot be verified as having the required sterility assurance level (SAL) of 10-6. Due to the recall of these pre-filled syringes by nurse assist, Avanos has made the decision to recall the mic gastric - jejunal feeding tube kits product. While the sterile water in the Nurse Assist, LLC pre-filled syringe is used to fill the retention balloon of the mic gastric - jejunal feeding tube, there is a small risk that the water will come into contact with a patient's surgical site. Any open wound exposed to non-sterile products could potentially put the patient at risk of infection. The pre-filled syringe is the only item in the kit which is affected by the Nurse Assist recall. All other components of the kit have been sterilized. Out of an abundance of caution, however, Avanos is asking their customers to scrap or return all affected mic gastric - jejunal feeding tube kits. Recall start date: January 16, 2024

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

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