FDAFDA · Food and drugs·Recall number Z-0867-2024
MB215R - MILLS DUROGRIP TC Micro Needle Holder, straight, 8:, (203 mm), "TC MILLS NDLE HOLDRRND HNDLSTR203MM"
Published February 7, 2024 · Recall initiated: December 29, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Aesculap Inc
- Distributor
- US Nationwide distribution in the states of CA, CO, FL, ID, KY, MD, MO, MT, NV, NY, OR, PA, RI, TN, TX, VA.
- Lot
- UDI-DI 4046955075379 Firm did not identify affected lots or expiration date. Affected product was distributed between November 23, 2022 and October 6, 2023.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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