Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTNL
Reported: April 10, 2024 Initiated: February 28, 2024 #Z-1466-2024
Product Description
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTNL
Reason for Recall
The potential for trocar seal disengagement when using mesh products incorrectly with the device.
Details
- Recalling Firm
- Covidien, LP
- Units Affected
- 315,716 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Aruba, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Colombia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, French Guiana, French Polynesia, Germany, Gibraltar, Greece, Guadeloupe, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea, Republic Of, Luxembourg, Macao, Malaysia, Malta, Martinique, Mayotte, Mexico, Netherlands, New Caledonia, New Zealand, Nigeria, Northern Ireland, Norway, Oman, Poland, Portugal, Puerto Rico, Reunion, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Turkey, United Arab Emirates, United Kingdom, United States, Uzbekistan, Viet Nam, Virgin Islands, U.S.;
- Location
- North Haven, CT
Frequently Asked Questions
What product was recalled? ▼
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTNL. Recalled by Covidien, LP. Units affected: 315,716 units.
Why was this product recalled? ▼
The potential for trocar seal disengagement when using mesh products incorrectly with the device.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 10, 2024. Severity: Moderate. Recall number: Z-1466-2024.
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