FDAClass IIMay 31, 2017

StatLock¿ IV Premium Catheter Stabilization Device recall

StatLock¿ IV Premium Catheter Stabilization Device, product code IV0570. sterile. Packaging: packaged as single units in tyvek to film pouches, the product is distributed in cartons containing 25 devices and cases containing 250 devices.

Why was StatLock¿ IV Premium Catheter Stabilization Device recalled?

StatLockTM IV Premium Catheter Stabilization Device may contain an incorrectly sized retainer clip.

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 Number JUAQF675, Exp 2/28/2019

Product
StatLock¿ IV Premium Catheter Stabilization Device, product code IV0570. sterile. Packaging: packaged as single units in tyvek to film pouches, the product is distributed in cartons containing 25 devices and cases containing 250 devices.
Recalling firm
Bard Access Systems Inc.
Quantity
4,500 units
Distribution
Nationwide Distribution - Internationally to Canada. No govt/VA/Military consignees.
Recall date
May 31, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls