Z-0866-2024 Class II Ongoing
FDA device recall Z-0866-2024 was initiated by Aesculap Inc on December 29, 2023 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 53.
Recall Details
- Product Type
- Devices
- Report Date
- February 7, 2024
- Initiation Date
- December 29, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 53
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.
Distribution Pattern
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.