Important Safety Alerts

It has come to our attention that the medical device manufacturer, Nestle HealthCare Nutrition, Inc. has initiated a medical device field safety corrective action concerning Compat Nasogastric Feeding Tubes with universal "Y" adapter and Stretch-Lok strap (COMPAT NG Tubes). The affected models are Compat Nasogastric Feeding Tube 8Fr, 10Fr and 12 Fr. The affected lots are:

1. 08211Z, 14212U, 35411H, 02412K, 14611P, 01413G, 08712W, 21512Y for Compat Nasogastric Feeding Tube 8Fr;
2. 08712D , 05312N , 08111M, 10211E, 13712W, 21512F, 01613G for Compat Nasogastric Feeding Tube 10Fr; and
3. 05912F , 01211AV, 04111P, 04111V, 05812F, 21512G, 01513N, 06313N, 23412BV, 34712V, 35411U, 04111D for Compat Nasogastric Feeding Tube 12Fr.

According to the manufacturer, this recall has been initiated due to the fact that some of the COMPAT NG Tubes have been delivered in an insufficiently sealed pouch, thus compromising the sterility claimed on the label. The manufacturer assures customers that all COMPAT NG Tubes have gone through the sterilization process and there have been no complaints associated with the recalled product. However, the manufacturer is recalling the affected products because the sterility claim on the label cannot be 100% certified and verified.

Patient safety risk is considered negligible for the following reasons:

• The gastrointestinal tract normally contains many different bacteria species;
• Nasogastric tubes become non-sterile as soon as they are placed through the nasal cavity;
• If brought into a sterile environment such as an operating room because of the " sterile" labeling, standard operating procedures in those environments would minimize the chance of contamination via gloves or a similar mechanism.
• Other products on the market with the same intended use are sold non-sterile.

According to the local supplier, the affected products have been distributed in Hong Kong.

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 26 July 2013
Revised on 8 August 2013