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Recall Observatory FDA recall evidence

Device product

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

Z-0867-2024

December 29, 2023

Class II

Product summary

Firm
Aesculap Inc
Event
Event 93793
Status
Ongoing
Classification
Class II
Quantity
60
Official record key
device-enforcement:Z-0867-2024

Official wording

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.

Code information: UDI-DI 4046955075379 Firm did not identify affected lots or expiration date. Affected product was distributed between November 23, 2022 and October 6, 2023.

Distribution pattern: US Nationwide distribution in the states of CA, CO, FL, ID, KY, MD, MO, MT, NV, NY, OR, PA, RI, TN, TX, VA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.