FDAClass IIMay 6, 2015

PowerLoc MAX Safety Winged Infusion Set recall

PowerLoc MAX Safety Winged Infusion Set, Product Code 0132215 The PowerLoc MAX Safety Winged Infusion Set is intended for use in the administration of…

Why was PowerLoc MAX Safety Winged Infusion Set recalled?

Bard Access Systems is conducting a field action due to the potential that an incorrect Maximum Flow rate label associated to the power injection IFU for the PowerLoc MAX Safety Infusion Set (SWIS) was attached to the outside of the unit pouch.

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?

Lot D430107

Product
PowerLoc MAX Safety Winged Infusion Set, Product Code 0132215 The PowerLoc MAX Safety Winged Infusion Set is intended for use in the administration of…
Recalling firm
Bard Access Systems
Quantity
700 units
Distribution
US Distribution to states of: GA and MN.
Recall date
May 6, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
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