Recall Z-1170-2024 ยท LWK Razor, Surgical
3M Company - Health Care Business
3M Specialty Blade Assembly, REF 9660,70-2011-8491-1, 7100213026, used with used with 3M Surgical Clipper Catalog Number 9661L
| Date | Feb 21, 2024 (initiated Jan 12, 2024) |
| Status | Open, Classified |
| Reason | 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 |
| Root cause | Under Investigation by firm |
| Action | 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 patie |
| Quantity | 764,580 blades |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.