FDAClass IIFebruary 14, 2018

6.6F Plastic Dignity¿ Low Profile CT Port W/Attachable recall

6.6F Plastic Dignity¿ Low Profile CT Port W/Attachable ChronoFlex¿ Polyurethane Catheter, Catalog # MRCTI66041, UDI#- 884908031157 Product Usage…

Why was 6.6F Plastic Dignity¿ Low Profile CT Port W/Attachable recalled?

The kit was packaged with the incorrect introducer needle size. The label indicates the kit contains an 18G Needle w/Echo Tip. The kits were packaged with a 21G Needle w/Echo Tip.

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 # MHGB030 Exp. Date 2020-07-30

Product
6.6F Plastic Dignity¿ Low Profile CT Port W/Attachable ChronoFlex¿ Polyurethane Catheter, Catalog # MRCTI66041, UDI#- 884908031157 Product Usage…
Recalling firm
Medical Components, Inc dba MedComp
Quantity
65 units
Distribution
Arabia, Australia, Israel, Brunei & Jamaica
Recall date
February 14, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls