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U.S. Department of Health and Human Services

Class 2 Device Recall Aesculap TC MILLS NDLE HOLDRRND HNDLSTR203MM

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 Class 2 Device Recall Aesculap TC MILLS NDLE HOLDRRND HNDLSTR203MMsee related information
Date Initiated by FirmDecember 29, 2023
Date PostedJanuary 31, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0867-2024
Recall Event ID 93793
Product Classification Instrument, ligature passing and knot tying - Product Code HCF
ProductMB215R - MILLS DUROGRIP TC Micro Needle Holder, straight, 8:, (203 mm), "TC MILLS NDLE HOLDRRND HNDLSTR203MM"
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.
Recalling Firm/
Manufacturer		 Aesculap Inc
3773 Corporate Pkwy
Center Valley PA 18034-8217
For Additional Information ContactQuality Assurance
833-425-1464
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn 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.
Quantity in Commerce60
DistributionUS Nationwide distribution in the states of CA, CO, FL, ID, KY, MD, MO, MT, NV, NY, OR, PA, RI, TN, TX, VA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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