FDAClass IINovember 16, 2016

SB (Sumitomo Bakelite Co recall: Labeling Error

SB (Sumitomo Bakelite Co.,) Electrosurgical Knife Size: Working Length 1.8M Maximum OD 2.6mm. Product Usage: The SB Knife is a single-use sterile…

Why was SB (Sumitomo Bakelite Co recalled?

Mislabeled product: Sterilization pouch and carton labeled as Standard Type instead of Short type

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.: 60564713

Product
SB (Sumitomo Bakelite Co.,) Electrosurgical Knife Size: Working Length 1.8M Maximum OD 2.6mm. Product Usage: The SB Knife is a single-use sterile…
Recalling firm
Akita Sumitomo Bakelite Co., Ltd.
Quantity
8 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