MB215R - MILLS DUROGRIP TC Micro Needle Holder, straight, 8:, (203 mm), "TC MILLS NDLE HOLDRRND H...
FDA Recall #Z-0867-2024 — Class II — December 29, 2023
Product Description
MB215R - MILLS DUROGRIP TC Micro Needle Holder, straight, 8:, (203 mm), "TC MILLS NDLE HOLDRRND HNDLSTR203MM"
Reason for Recall
Needle Holder MB215R was inadvertently distributed as MB362R. Similarly, MB362R was distributed as MB215R during the affected distribution date range. The issue may lead to a short delay in procedure.
Recalling Firm
Aesculap Inc — Center Valley, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
60
Distribution
US Nationwide distribution in the states of CA, CO, FL, ID, KY, MD, MO, MT, NV, NY, OR, PA, RI, TN, TX, VA.
Code Information
UDI-DI 4046955075379 Firm did not identify affected lots or expiration date. Affected product was distributed between November 23, 2022 and October 6, 2023.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated