FDAClass IIJuly 31, 2019

Powerport Clearvue Isp recall

POWERPORT CLEARVUE isp, 6F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE isp, 8F CHRONOFLEX Catheter, Intermediate NAUTILUS…

Why was Powerport Clearvue Isp recalled?

Certain NAUTILUS DELTA Port Kit product code / lot number combinations may be at risk of experiencing a lack of or a loss of the intravascular ECG signal during port placement procedures when used in combination with the NAUTILUS DELTA" TCS.

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?

REBR1147, REBR1148, REBR1149, REBT0471, RECQ2162 and REBR1150

Product
POWERPORT CLEARVUE isp, 6F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE isp, 8F CHRONOFLEX Catheter, Intermediate NAUTILUS…
Recalling firm
Bard Peripheral Vascular Inc
Quantity
95 units
Distribution
US Nationwide Distribution in the states of FL, CO, WI, OH, IL, KS, AZ, WV, CT, PA, AL, MI and VA
Recall date
July 31, 2019
Classification
Class II
Status
Completed
Agency
FDA (device)
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