FDAClass IIMarch 21, 2018

TFE Coated Curved Newton LLT recall

TFE Coated Curved Newton LLT

Why was TFE Coated Curved Newton LLT recalled?

Label does not state that the product is heparin-coated.

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?

Catalog # TSCFNB-35-180-SPENCERMOD- BH Affected lots to include: 3741882 - 6142463 F3884311 - F4903643 NS5044201 - NS5963180

Product
TFE Coated Curved Newton LLT
Recalling firm
Cook Inc.
Quantity
3,364
Distribution
Nationally
Recall date
March 21, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls