| Class 2 Device Recall LigaSure Blunt Tip Laparoscopic Sealer/Divider, NanoCoated | |
Date Initiated by Firm | December 06, 2021 |
Date Posted | January 13, 2022 |
Recall Status1 |
Terminated 3 on May 11, 2023 |
Recall Number | Z-0495-2022 |
Recall Event ID |
89182 |
510(K)Number | K162941 |
Product Classification |
Electrosurgical, cutting & coagulation & accessories - Product Code GEI
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Product | LigaSure Blunt Tip Laparoscopic Sealer/Divider, Nano-Coated, Product Number LF1837 |
Code Information |
UDI: 20884521705880 10884521705883;
Lot Number: 11320187X |
Recalling Firm/ Manufacturer |
Covidien Llc 15 Hampshire St Mansfield MA 02048-1113
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Manufacturer Reason for Recall | Customers reported that the device jaws were difficult to open or would not open following application on tissue. Use of a device with this potential assembly issue could result in the potential for bleeding, unintended tissue injury or loss, and delay in treatment while an alternate device is obtained. |
FDA Determined Cause 2 | Device Design |
Action | URGENT MEDICAL DEVICE RECALL notification letters dated 12/2021 were sent to customers.
Customer Action Required:
1. Please immediately quarantine and discontinue use of the affected item code with the associated lot number listed above.
2. Please return affected product as indicated below. All products from the affected item code and associated lot number must be returned.
3. If you have distributed the product item code and lot number listed above, please promptly forward the information from this letter to those recipients.
4. Complete the Recalled Product Return Form even if you do not have inventory and email it to rs.anzrecalls@medtronic.com
We regret any inconvenience this may cause. We are committed to patient safety and appreciate your prompt attention to this matter. If you have any questions regarding this communication, please do not hesitate to contact Azi Hosseini on +61 428 464 838, or azi.hosseini@medtronic.com |
Quantity in Commerce | 504 devices |
Distribution | Worldwide Distribution in the countries of Australia, Austria, Belgium, Czech Republic, France, Germany, Ireland, Kazakhstan, Netherlands, Spain, United Kingdom. No US distribution. |
Total Product Life Cycle | TPLC Device Report |
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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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = GEI
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