FDAClass IIJune 26, 2019

ETHIBOND EXCEL¿ Polyester Suture-ETHIBOND Green 75cm recall: Endotoxin

ETHIBOND EXCEL¿ Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1 Product Code: X425H Product Usage: ETHIBOND EXCEL Suture is intended for…

Why was ETHIBOND EXCEL¿ Polyester Suture-ETHIBOND Green 75cm recalled?

Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot

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 Code: PBQ426

Product
ETHIBOND EXCEL¿ Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1 Product Code: X425H Product Usage: ETHIBOND EXCEL Suture is intended for…
Recalling firm
Ethicon, Inc.
Quantity
1296 eaches
Distribution
Worldwide - US Nationwide Distribution - IA, NJ, RI, TX, WV Foreign: Canada
Recall date
June 26, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls