FDAFDA · Food and drugs·Recall number Z-1243-2024
DISP.TROCAR W. DILATING PIN 10/110MM, Product Code EK224SU. For use in laparoscopic procedures.
Published March 13, 2024 · Recall initiated: January 9, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The sterile blister packaging may be damaged, and sterility may be compromised.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Aesculap Inc
- Distributor
- Worldwide - US Nationwide distribution in the states of KS, NJ and NY. The country of Canada.
- Lot
- Product Code: EK224SU; UDI/DI: 04046963620424; Batch Numbers (Expiration Date): 52658689 (12/08/2023), 52625350 (07/31/2025), 52567841 (11/30/2024);
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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