Gastroduodenal sump tubes recalled after anti-reflux valve breakage complaints
Cardinal Health is recalling all lots of Salem Sump PVC gastroduodenal 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 Salem Sump PVC Gastroduodenal Tube in 10 Fr/Ch x 90 cm (product code 1180264408), 12 Fr/Ch x 114 cm (1180264416) and other sizes.
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: 1180264408 Salem Sump" PVC Gastroduodenal Tube, 10 Fr/Ch (3.3 mm) x 90 cm 1180264416 Salem Sump" PVC Gastroduodenal Tube, 12 Fr/Ch (4.0 mm) x 114 cm 1180264424 Salem Sump" PVC Gastroduodenal Tube, 14 Fr/Ch (4.7 mm) x 114 cm
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Gastric tube
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 (8)
- 20 Fr/Ch (3.3mm)
- 108 cm 10192253007015 8888264804 Salem Sump PVC Gastroduodenal Tube
- 14 Fr/Ch (4.7mm)
- 108 cm 10192253012422 8888264861 Salem Sump PVC Gastroduodenal Tube
- 16 Fr/Ch (5.3mm)
- 108 cm 10192253012439 8888264887 Salem Sump PVC Gastroduodenal Tube
- 18 Fr/Ch (6.0mm)
- 108 cm 10192253012446 All Lots
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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