MB215R - MILLS DUROGRIP TC Micro Needle Holder, straight, 8:, (203 mm), "TC MILLS NDLE HOLDRRND HNDLSTR203MM"
FDA device recall Z-0867-2024 · posted 2024-01-31 · Open, Classified
Recall details
- Recalling firm
- Aesculap Inc
- 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.
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- HCF
- Quantity affected
- 60
- Distribution
- US Nationwide distribution in the states of CA, CO, FL, ID, KY, MD, MO, MT, NV, NY, OR, PA, RI, TN, TX, VA.
- Date initiated
- 2023-12-29
- Date posted
- 2024-01-31
- Location
- Center Valley, PA
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