FDAClass IIJuly 25, 2018

Presource PBDS recall

Presource PBDS, Kit, Common Diabetes. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin prep 2% CHG, a packet of 4…

Why was Presource PBDS recalled?

A defect in the seal of the Gatorade pouch contained in kits caused the pouch to leak within a limited portion of the kit.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Product Code SP1692448A (Lot Numbers 820353, 821937, 822523, 826984, 827083, 828090, 830102), Product Code SP1692448B (Lot Number 849805)

Product
Presource PBDS, Kit, Common Diabetes. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin prep 2% CHG, a packet of 4…
Recalling firm
Cardinal Health 200, LLC
Quantity
8,928 kits total
Distribution
US Nationwide Distribution in the states of California.
Recall date
July 25, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls