Recall Z-0866-2024— 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: MB362R - JACOBSON DUROGRIP TC Micro Needle Holder, straight, 8 3/4", (220 mm), "TC JACOBSON NDL HLD STR JAW 220MM";. 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
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.