PlainRecalls
FDA Devices Moderate Class II Ongoing

MB215R - MILLS DUROGRIP TC Micro Needle Holder, straight, 8:, (203 mm), "TC MILLS NDLE HOLDRRND HNDLSTR203MM"

Reported: February 7, 2024 Initiated: December 29, 2023 #Z-0867-2024

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.

Details

Recalling Firm
Aesculap Inc
Units 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.
Location
Center Valley, PA

Frequently Asked Questions

What product was recalled?
MB215R - MILLS DUROGRIP TC Micro Needle Holder, straight, 8:, (203 mm), "TC MILLS NDLE HOLDRRND HNDLSTR203MM". Recalled by Aesculap Inc. Units affected: 60.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 7, 2024. Severity: Moderate. Recall number: Z-0867-2024.