Kentec Medical Recalls ENFit Polyurethane and Silicone Feeding Tubes
Kentec Medical is recalling ENFit feeding tubes because the plastic tethered closure cap may fracture or break, potentially delaying enteral feeding and medication administration.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 risk-of-harm product (medical device) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Kentec Medical, Inc. is recalling 4,710 units of Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes, catalog number ENF-Y60P-50. The affected product is a 6 fr. 50 cm ENFit Enteral Feeding Tube with Y-Port, sterile and single use only. The specific lot number is KS1810008.
The recall is being issued because the feeding tube's plastic tethered closure cap may possibly fracture or break. This defect could result in two potential health hazards: first, enteral feeding and medication administration could be delayed until a replacement tube is placed in the patient; second, patients could be unnecessarily overexposed to radiation if multiple x-rays are required to confirm the placement of a new tube.
The affected units were distributed in California, Iowa, and Virginia. Consumers and healthcare facilities should stop using the affected feeding tubes and contact Kentec Medical 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-Y60P-50 (6 fr. 50 cm ENFit Enteral Feeding Tube with Y-Port).
- Manufacturer
- Kentec Medical, Inc
- Affected units
- 4,710
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: KS1810008
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
Same manufacturer · Kentec Medical, Inc
See all →- HighKentec Medical Recalls ENFit Polyurethane and Silicone Feeding Tubes
FDA (Devices) · 2020-07-15
- HighKentec Medical Recalls ENFit Polyurethane and Silicone Feeding Tubes
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- HighKentec Medical Recalls ENFit Feeding Tubes Due to Cap Fracture Risk
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- HighKentec Medical Recalls ENFit Feeding Tubes Due to Cap Fracture Risk
FDA (Devices) · 2020-07-15
- HighKentec Medical Recalls ENFit Enteral Feeding Tubes Due to Cap Fracture Risk
FDA (Devices) · 2020-07-15
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