DISP.TROCAR W. DILATING PIN 10/110MM, Product Code EK224SU. For use in laparoscopic procedures.
FDA device recall Z-1243-2024 · posted 2024-03-01 · Open, Classified
Recall details
- Recalling firm
- Aesculap Inc
- Reason for recall
- The sterile blister packaging may be damaged, and sterility may be compromised.
- Action taken
- 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.
- Root cause
- Packaging change control
- Status
- Open, Classified
- Product code
- GCJ
- Quantity affected
- 12 pieces
- Distribution
- Worldwide - US Nationwide distribution in the states of KS, NJ and NY. The country of Canada.
- Date initiated
- 2024-01-09
- Date posted
- 2024-03-01
- Location
- Center Valley, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HYBRID TROCAR SYSTEM (K101937) | Aesculap, Inc. | 2010-08-11 |