Medtronic DLP Retrograde Cannula 13FR Model 94913L Recall
Medtronic is recalling certain lots of DLP Retrograde Cannula (Model 94913L), a cardiopulmonary bypass catheter, due to potential sterile barrier breaches. The affected device was distributed worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a high-risk medical device (cardiopulmonary bypass catheter). A sterile barrier breach on such a device creates significant risk of harm, even though no illnesses or injuries have been reported in the source text.
Plain-English summary
Medtronic Perfusion Systems is recalling certain lots of the Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913L, a cardiopulmonary bypass vascular catheter. The recall affects 481 units with GTINs 00643169454460 (Lot 0231665646) and 20643169454464 (Lots 0231665648 and 0231665646).
The product has the potential for a sterile barrier breach. Affected units were distributed worldwide, including throughout the United States and to Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Cyprus, Denmark, France, Germany, Hong Kong, Hungary, Italy, Japan, Latvia, Lithuania, Malaysia, Moldova, Morocco, Netherlands, Norway, Panama, Poland, Russia, Serbia, Singapore, South Africa, South Korea, Spain, Suriname, Sweden, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, and Vietnam.
Healthcare facilities that received this product should verify their lot numbers against those listed. Facilities with affected units should not use the recalled cannulas and should follow appropriate procedures for handling the affected devices.
The recalled product
- Product
- Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913L; Cardiopulmonary bypass vascular catheter
- Manufacturer
- Medtronic Perfusion Systems
- Hazard
- sterile-barrier-breach
- contamination-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- GTIN 00643169454460
- Lot Numbers: 0231665646
- GTIN 20643169454464
- 0231665648.
Distribution
Distributed nationwide across the United States.