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U.S. Department of Health and Human Services

Class 2 Device Recall Aesculap Disposable Trocar

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  Class 2 Device Recall Aesculap Disposable Trocar see related information
Date Initiated by Firm January 09, 2024
Date Posted March 01, 2024
Recall Status1 Open3, Classified
Recall Number Z-1245-2024
Recall Event ID 93856
510(K)Number K101937  
Product Classification Laparoscope, general & plastic surgery - Product Code GCJ
Product DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK234SU. For use in laparoscopic procedures.
Code Information Product Code: EK234SU; UDI/DI: 04046963620462; Batch Numbers (Expiration Date): 52573073 (12/08/2023);
Recalling Firm/
Manufacturer		 Aesculap Inc
3773 Corporate Pkwy
Center Valley PA 18034-8217
For Additional Information Contact Cynthia Bauer
800-258-1946
Manufacturer Reason
for Recall		 The sterile blister packaging may be damaged, and sterility may be compromised.
FDA Determined
Cause 2		 Packaging change control
Action URGENT MEDICAL DEVICE RECALL NOTIFICATION letters dated January 5, 2024 were sent to customers. 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 Commerce 6 pieces
Distribution Worldwide - US Nationwide distribution in the states of KS, NJ and NY. The country of Canada.
Total Product Life Cycle TPLC 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.
510(K) Database 510(K)s with Product Code = GCJ and Original Applicant = AESCULAP, INC.
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