FDAClass IINovember 16, 2016

SB Knife -Electrosurgical Knife recall: Labeling Error

SB Knife -Electrosurgical Knife, Sterile Size: Working Length 2.3M Maximum OD 2.6mm. Product Usage: The SB Knife is a single-use sterile…

Why was SB Knife -Electrosurgical Knife recalled?

Mislabeled product: Sterilization pouch and carton box labeled as Standard type instead of Jr type-Long

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.: 60564711

Product
SB Knife -Electrosurgical Knife, Sterile Size: Working Length 2.3M Maximum OD 2.6mm. Product Usage: The SB Knife is a single-use sterile…
Recalling firm
Akita Sumitomo Bakelite Co., Ltd.
Quantity
15 units
Distribution
US in the states of MA
Recall date
November 16, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls