FDAClass IIDecember 17, 2014

6F x 60 cm Dual Lumen CT PICC recall: Endotoxin

6F x 60 cm Dual Lumen CT PICC, Ref No. PFM2CT6D Product Usage:The PFM CT PICC catheter is indicated for short or long term peripheral access to the…

Why was 6F x 60 cm Dual Lumen CT PICC recalled?

PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.

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 No. 1301-038

Product
6F x 60 cm Dual Lumen CT PICC, Ref No. PFM2CT6D Product Usage:The PFM CT PICC catheter is indicated for short or long term peripheral access to the…
Recalling firm
Pfm Medical Inc
Quantity
90 units
Distribution
Worldwide Distribution - US Nationwide in the states of MA, NC, UT, PA, TX, OH, LA and worldwide to: Germany and Malaysia.
Recall date
December 17, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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