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FDAFDA · Food and drugs·Recall number Z-1170-2024

3M Specialty Blade Assembly, REF 9660,70-2011-8491-1, 7100213026, used with used with 3M Surgical Clipper Catalog Number 9661L

Published February 28, 2024 · Recall initiated: January 12, 2024

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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 to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
3M Company - Health Care Business
Distributor
Worldwide distribution.
Lot
UDI/DI 50707387789294 (shipper), 30707387789290 (tray), all lot codes
Risk classification
Class II
Area (FDA)
device
Country
United States

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