MB362R - JACOBSON DUROGRIP TC Micro Needle Holder, straight, 8 3/4", (220 mm), "TC JACOBSON NDL H...

FDA Recall #Z-0866-2024 — Class II — December 29, 2023

Recall #Z-0866-2024 Date: December 29, 2023 Classification: Class II Status: Ongoing

Product Description

MB362R - JACOBSON DUROGRIP TC Micro Needle Holder, straight, 8 3/4", (220 mm), "TC JACOBSON NDL HLD STR JAW 220MM";

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

53

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 4046955075546 Firm did not identify affected lots or expiration date. Affected product was distributed between November 23, 2022 and October 13, 2023.

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated