United StatesMedtronic GUNDRY and DLP Retrograde Cannula manual-inflate silicone body cardiopulmonary bypass vascular catheters (models 94113T, 94115T, 94215T, 94665, 94725, 94913, 94913L, 94915, 94965) sold worldwide are included in this recall and can be identified by the GTINs and lot numbers listed in the notice. The products were recalled because certain lots have the potential for a sterile barrier breach.
What's being recalled
Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmonary bypass vascular catheter
Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94115T; Cardiopulmonary bypass vascular catheter
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T; Cardiopulmonary bypass vascular catheter
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94665; Cardiopulmonary bypass vascular catheter
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardiopulmonary bypass vascular catheter
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913; Cardiopulmonary bypass vascular catheter
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913L; Cardiopulmonary bypass vascular catheter
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94915; Cardiopulmonary bypass vascular catheter
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965; Cardiopulmonary bypass vascular catheter
Recalling firm: Medtronic Perfusion Systems, Brooklyn Park, MN, United States.
How to identify it
GTIN 00673978188447, Lot Numbers: 0231651336; GTIN 20643169454877, Lot Numbers: 0231651336, 0231651345, 0231651385, 0231651389, 0231651396, 0231667029, 0231667046, 0231757975, 0231758248, 0231758259, 0231936467, 0231982226, 0232274424, C232287618, C232287619, C232287620, C232598550, C232598552. GTIN 00643169454521, Lot Numbers: 0231545565, C231958117; GTIN 20643169454525, Lot Numbers: 0231545557, 0231545560, 0231545565, 0231545567, 0231545569, 0231592142, 0231592228, 0231592241, 0231665664, 0231665707, 0231665708, 0231665711, 0231665712, 0231665713, 0231665714, 0231665715, 0231665716, 0231667178, 0231823613, 0231823689, 0231823700, 0231846134, 0231862819, 0231912810, C231958117, C231958118, C231958119, C231958120, C232287623. GTIN 20643169454556, Lot Numbers: 0231881762, 0231881786, 0231931962, 0231962106, C233032040. GTIN 00643169454705, Lot Numbers: 0231823435, 0231961203; GTIN 20643169454709, Lot Numbers: 0231823435, 0231823478, 0231961203. GTIN 00643169454736, Lot Numbers: 0231650787, 0231758255, 0231862812, C231966207; GTIN 00673978188713, Lot Numbers: 0231937422; GTIN 20643169454730, Lot Numbers: 0231650787, 0231650793, 0231758250, 0231758255, 0231758279, 0231758282, 0231823523, 0231862812, 0231937422, C231965721, C231966207, C232428221, C232430086. GTIN 20643169454785, Lot Numbers: 0231757977, 0231757978, 0231757985, 0231758246, 0231758249, 0231758254, 0231758262, 0231772525, 0231792898, 0232066774, 0232112345, 0232114667, C232276641, C232277146, C232277149, C232949860, C232949864. GTIN 00643169454460, Lot Numbers: 0231665646; GTIN 20643169454464, Lot Numbers: 0231665646, 0231665648. GTIN 20643169454808, Lot Numbers: 0231859673. GTIN 20643169454815, Lot Numbers: 0231665658, C231786900.
The hazard
Certain lots of product have the potential for a sterile barrier breach.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
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.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)