Recall Z-0867-2024— Aesculap Inc
Class II · Ongoing
Class II FDA medical device recall by Aesculap Inc, initiated 2023-12-29. FDA's recall record names no specific 510(k) clearance for this event. Product: MB215R - MILLS DUROGRIP TC Micro Needle Holder, straight, 8:, (203 mm), "TC MILLS NDLE HOLDRRND HNDLSTR203MM". Reason: 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
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-12-29
- Firm location
- Center Valley, PA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.