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Mic* gastric-jejunal feeding tube with enfit connectors (endoscopic radiologic placement kit)

Official notice

4 Dec 2024

MediumHealth Canada

An official Health Canada notice concerns Mic* gastric-jejunal feeding tube with enfit connectors (endoscopic radiologic placement kit). 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 Published 2024-12-04.

What to do now

Contact the manufacturer if you require additional information.

Recall number

76639

Official notice

2024-12-04

The hazard

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

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

76639

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Affected products

Product 1

Affected products - Mic* Gastric-Jejunal Feeding Tube With Enfit Connectors (Endoscopic/Radiologic Placement Kit), Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 8250-16-30 8250-18-22 8250-22 8250-18 8250-18-30 8250-16

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand: Avanos Medical, Mic* Gastric-jejunal Feeding Tube With Enfit Connectors.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

76639

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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