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Open, Classified

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

FDA Recall Z-0867-2024 · Posted 2024-01-31

Recalling FirmAesculap Inc
Recall StatusOpen, Classified
Product CodeHCF
Date Initiated2023-12-29
Product Quantity60

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.

Firm Action

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

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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