Z-2222-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 27, 2026
- Initiation Date
- April 21, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 260 units
Product Description
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965; Cardiopulmonary bypass vascular catheter
Reason for Recall
Certain lots of product have the potential for a sterile barrier breach.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Cyprus, Denmark, France, Germany, Hong Kong, Hungary, Italy, Japan, Latvia, Lithuania, Malaysia, Moldova, Republic Of, Morocco, Netherlands, Norway, Panama, Poland, Russia, Serbia, Singapore, South Africa, South Korea, Spain, Suriname, Sweden, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, Vietnam.
Code Information
GTIN 20643169454815, Lot Numbers: 0231665658, C231786900.