Moderate riskFDA DeviceClass II

Vesco Q 40mm feed set recalled for possible dosing inaccuracy

Vesco Medical LLC is recalling the Vesco Q 40mm Screw Cap Feed Set, Model VED-052, used with feeding pumps. The feeding pump may deliver enteral fluids outside its labeled accuracy of plus or minus 5%, which could over-deliver or under-deliver feeding relative to the prescribed dose. The notice says any effects would likely be temporary or medically reversible, with a remote chance of serious harm, and no injuries have been reported.

From the FDA notice · Read the official notice ↗

What to do

  1. Contact your care team or prescriber before changing your feeding plan, and ask them how to monitor for dosing problems.
  2. Check whether your feed set is model VED-052 with UDI-DI 00850002550474 and a lot manufactured through 12/20/2204 (as written in the notice).
  3. The notice doesn't say how to get a replacement or refund; contact Vesco Medical LLC for instructions.

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Vesco Q 40mm Screw Cap Feed Set, Model Number VED-052
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 7 products — see all of them.

Details

Units affected
2,880 units
Illnesses reported
None reported
Manufactured in
60 Collegeview Rd Space 144, Westerville, Ohio, United States
Classification
Class II
Recall number
Z-0376-2027

In the FDA's words

Description
Vesco Q 40mm Screw Cap Feed Set, Model Number VED-052 The feeding pump may deliver enteral fluids outside its labeled accuracy specification of +/-5%. This inaccuracy can result in over-delivery or under-delivery of enteral fluids relative to the prescribed dose, if proper controls are not in place. Over- or under-delivery of enteral nutrition through the pump and associated feed sets could cause temporary or medically reversible adverse health consequences, with a remote probability of serious adverse health consequences. UDI-DI 00850002550474; Lot Numbers: all lots manufactured through 12/20/2204 Distribution: US Nationwide distribution. Affected quantity: 2,880 units
Hazard
The feeding pump may deliver enteral fluids outside its labeled accuracy specification of +/-5%. This inaccuracy can result in over-delivery or under-delivery of enteral fluids relative to the prescribed dose, if proper controls are not in place. Over- or under-delivery of enteral nutrition through the pump and associated feed sets could cause temporary or medically reversible adverse health consequences, with a remote probability of serious adverse health consequences.

7 products in this recall

Vesco Q pumps, feed sets recalled for possible dosing inaccuracy

Vesco Medical is recalling 7 Vesco Q products: the Vesco Q Enteral Feeding Pump (model VED-701) and six Vesco Q feed sets (models VED-050, VED-051, VED-052, VED-053, VED-054 and VED-059). The pump may deliver enteral fluids outside its labeled accuracy of plus or minus 5%, so feeds may be over- or under-delivered compared with the prescribed dose. The agency says this could cause temporary or medically reversible effects, with a remote chance of serious harm. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

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