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3M Specialty Blade Assembly, REF 9660,70-2011-8462-2… recallZ-1169-2024 · 3M Company - Health Care Business · initiated Jan 12, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from 3M Company - Health Care Business or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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 41C (105.8F). " 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 60C (140F) and the Model 9660 blade maximum temperature may reach 77C (170.6F)."

FDA root cause category: Under Investigation by firm

What the company is doing

3M issued a Medical Device Safety Notification - First Notice to its consignees on 01/12/2024 via USPS certified mail and email. The notice explained the issue and its decision to notify its consignees of an added caution 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 41C (105.8F). " 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 60C (140F) and the Model 9660 blade maximum temperature may reach 77C (170.6F). Users were asked to take the following actions: "" Ensure this safety notification is passed to all those who need to be aware within your organization or to any department where the affected product has been transferred. " Continue to use the product as intended, following the additional caution statement above. " Complete the attached Customer Acknowledgement Form acknowledging that you have read and understood this letter and the additional caution statement. " Email the completed form to [email protected]." For additional questions or need to report an adverse event, contact the 3M Health Care Customer Helpline at 1-800-228-3957, option 7.

Recall details

Recall number
Z-1169-2024
Status
Open, Classified
Initiated by the company
Jan 12, 2024
Posted by the FDA
Feb 21, 2024
Recalling firm
3M Company - Health Care Business
Quantity
52,833,750 blades
Product code
LWK
Distribution
Worldwide distribution.

Product description

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

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 93825).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page