Kentec Medical Recalls ENFit Polyurethane and Silicone Feeding Tubes
Kentec Medical is recalling 710 ENFit feeding tubes because the plastic tethered closure cap may fracture or break, potentially delaying care or increasing radiation exposure.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of harm (delayed care and radiation exposure) where no specific injuries or illnesses have been reported, fitting the criteria for a High severity score.
Plain-English summary
Kentec Medical, Inc. is recalling 710 units of Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes (Catalog number ENF-60P-50, Lot Number KS1706021). The recall is due to a defect where the plastic tethered closure cap may possibly fracture or break.
The affected products are sterile, single-use enteral feeding tubes. The distribution was limited to California, Iowa, and Virginia. The primary health hazards associated with this defect are the potential delay in enteral feeding and medication administration until a replacement tube is placed, and the possibility of patients being unnecessarily overexposed to radiation if multiple x-rays are required to confirm the placement of a new tube.
Consumers and healthcare facilities should stop using the affected feeding tubes and contact Kentec Medical, Inc. for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-60P-50 (6 fr. 50 cm ENFit Enteral Feeding Tube).
- Manufacturer
- Kentec Medical, Inc
- Affected units
- 710
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number: KS1706021
Distribution
Part of a larger recall action
This product is one of 7 recalled by Kentec Medical, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 7 products in this recall →Related recalls
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See all →- HighKentec Medical Recalls ENFit Feeding Tubes Due to Cap Fracture Risk
FDA (Devices) · 2020-07-15
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- HighKentec Medical Recalls ENFit Feeding Tubes Due to Cap Fracture Risk
FDA (Devices) · 2020-07-15
- HighKentec Medical Recalls ENFit Polyurethane and Silicone Feeding Tubes
FDA (Devices) · 2020-07-15
- HighKentec Medical Recalls ENFit Polyurethane and Silicone Feeding Tubes
FDA (Devices) · 2020-07-15
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