ENFit sump tubes recalled after anti-reflux valve breakage complaints
Cardinal Health is recalling all lots of ENFit Salem Sump PVC tubes after complaints of anti-reflux valve breakage due to excessive force during use.
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: Scored 3 under the risk-of-harm criterion: complaints report valve breakage during use of a gastric tube, and no injuries are reported.
Plain-English summary
Salem Sump PVC Tubes are being recalled, covering the ENFit Salem Sump PVC Tube in 10 Fr 36 in (product code 8888264911E), 12 Fr 48 in (8888264929E), 14 Fr 48 in (8888264945E) and 16 Fr (8888264960E).
The firm has received complaints regarding Anti-Reflux Valve breakage due to excessive force during use, and is providing additional guidance for use. The record notes this is an expansion of an earlier action, RES 95214.
The recall covers all lots, distributed worldwide including nationwide in the United States. The FDA has classified the action as Class II.
The enforcement record describes the breakage complaints and reports no injuries. Facilities should follow Cardinal Health's updated guidance for use.
The recalled product
- Product
- Salem Sump PVC Tubes: Product Code/Product Name: 8888264911E ENFit" SALEM SUMP" PVC TUBE 10FR 36IN 8888264929E ENFit" SALEM SUMP" PVC TUBE 12FR 48IN 8888264945E ENFit" SALEM SUMP" PVC TUBE 14FR 48IN 8888264960E ENFit" Salem Sump" PVC Tube 16Fr 48IN 8888264986E ENFit" SA
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Gastric tube
Distribution
Part of a larger recall action
This product is one of 6 recalled by Cardinal Health 200, LLC 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.
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