MB215R - MILLS DUROGRIP TC Micro Needle Holder, straight, 8:, (203 mm), "TC MILLS NDLE HOLDRRND HNDLSTR203MM"
- Company
- Aesculap Inc
- Recall Initiated
- December 29, 2023
- Posted
- January 31, 2024
- Recall Number
- Z-0867-2024
- Quantity
- 60
- Firm Location
- Center Valley, PA
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
US Nationwide distribution in the states of CA, CO, FL, ID, KY, MD, MO, MT, NV, NY, OR, PA, RI, TN, TX, VA.
Lot / Code Info
UDI-DI 4046955075379 Firm did not identify affected lots or expiration date. Affected product was distributed between November 23, 2022 and October 6, 2023.
Root Cause
Nonconforming Material/Component
Action Taken
On December 29, 2023, the firm notified affected customers via URGENT MEDICAL DEVICE RECALL NOTIFICATION letters. Customers were instructed to cease use and quarantine all product subject to recall. Once Aesculap Customer Support receives the customer's acknowledgement form, they will contact the customer to arrange for credit and to have the current inventory returned.