FDAClass IIFebruary 28, 2024

3M Specialty Blade Assembly recall

3M Specialty Blade Assembly, REF 9660,70-2011-8462-2, 7100213114, used with used with 3M Surgical Clipper Catalog Number 9661L

Why was 3M Specialty Blade Assembly recalled?

3M has added the following cautionary statement regarding the use of the product: "Caution - To reduce the risk of burns, which if not avoided may result in minor injury: " Do not use on injured skin. " Do not leave clipper running unused in air without applying to skin for more than 1 minute as blade temperature may exceed 41¿C (105.8¿F). " Do not leave the clipper blade applied to the same location on the patient s skin for longer than 1 second as potential injury may occur; continuous motion of the clipper during use is required. Note: If clipper is left running unused in air for 10 minutes without applying to skin, the Model 9690 blade maximum temperature may reach 60¿C (140¿F) and the Model 9660 blade maximum temperature may reach 77¿C (170.6¿F)."

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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?

UDI/DI 50707387789003 (shipper), 30707387789009 (tray), all lot codes

Product
3M Specialty Blade Assembly, REF 9660,70-2011-8462-2, 7100213114, used with used with 3M Surgical Clipper Catalog Number 9661L
Recalling firm
3M Company - Health Care Business
Quantity
52,833,750 blades
Distribution
Worldwide distribution.
Recall date
February 28, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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