FDAClass IIMay 26, 2021

11g Direct Working Cannula Diamond TIP Mini recall

11G DIRECT WORKING CANNULA DIAMOND TIP MINI, CODE INTVMN-DWCD

Why was 11g Direct Working Cannula Diamond TIP Mini recalled?

Products labeled as sterile were distributed, but may not have been sterilized.

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: 2002437

Product
11G DIRECT WORKING CANNULA DIAMOND TIP MINI, CODE INTVMN-DWCD
Recalling firm
BIOPSYBELL S.R.L.
Quantity
75 units
Distribution
US Nationwide distribution in the states MS and KY.
Recall date
May 26, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls