FDA (Devices) recall action 85430
The FDA (Devices) publishes a recall like this one as 7 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 7 pages.
Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1) Enteral feeding and medication administration could be possibly delayed, until replacement tube is placed into patient (2) Patient could be unnecessarily overexposed to radiation if multiple x-rays are needed to confirm placement of a new tube, if x-ray is used as the placement confirmation method.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Kentec Medical is recalling 70 ENFit feeding tubes because the plastic tethered closure cap may fracture, potentially delaying care or causing unnecessary radiation exposure.
Kentec Medical is recalling 170 ENFit enteral feeding tubes because the plastic tethered closure cap may fracture or break, potentially delaying patient care.
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.
Kentec Medical is recalling 2,130 ENFit feeding tubes because the plastic tethered closure cap may fracture or break, potentially delaying patient care.
Kentec Medical is recalling 480 ENFit feeding tubes because the plastic tethered closure cap may fracture or break, potentially delaying patient care.
Kentec Medical is recalling ENFit feeding tubes because the plastic tethered closure cap may fracture or break, potentially delaying enteral feeding and medication administration.
Kentec Medical is recalling 2,850 ENFit feeding tubes because the plastic tethered closure cap may fracture or break, potentially delaying patient care.