FDAClass IIJuly 29, 2020

LoFric Origo recall

LoFric Origo, Tiemann, 16in, FR12 urinary catheters

Why was LoFric Origo recalled?

Wellspect Healthcare is voluntarily recalling certain LoFric¿ Origo" urethral catheters due to a potential defect which may be present in the catheters distal 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 # 450422

Product
LoFric Origo, Tiemann, 16in, FR12 urinary catheters
Recalling firm
Wellspect HealthCare (Division of DENTSPLY IH AB)
Quantity
N/A
Distribution
AL, AZ, CA, CT, FL, GA, IL, IN, KY, MA, MD, MI, MO, NC, NH, NJ, OH, PA, RI, SC, TX, VA and Australia, Brazil, Canada, European Union, China, South Korea, Kuwait, New Zeeland, Singapore, United Kingdom
Recall date
July 29, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls