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

FDA device recall Z-1170-2024 · posted 2024-02-21 · Open, Classified

Recall details

Recalling firm

3M Company - Health Care Business

Reason for recall

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)."

Action taken

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 3MFieldSafetyAction@montage72.com." For additional questions or need to report an adverse event, contact the 3M Health Care Customer Helpline at 1-800-228-3957, option 7.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

LWK

Quantity affected

764,580 blades

Distribution

Worldwide distribution.

Date initiated

2024-01-12

Date posted

2024-02-21

Location

Saint Paul, MN