FDAClass IIDecember 4, 2019

PowerPort isp M.R.I. Implantable Port with Attachable recall

PowerPort isp M.R.I. Implantable Port with Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter

Why was PowerPort isp M.R.I. Implantable Port with Attachable recalled?

Complaints received that products packaged with the incorrect introducer sheath size.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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: 1808060 Device Listing Number: D004935 UDI: (01)00801741027031(17)191130(10)RECS2407 Lot Number: RECS2407

Product
PowerPort isp M.R.I. Implantable Port with Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter
Recalling firm
Bard Peripheral Vascular Inc
Quantity
900 units
Distribution
US - Nationwide OUS - None
Recall date
December 4, 2019
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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