Medtronic GUNDRY Retrograde Cannula Model 94113T sterile barrier recall
Medtronic is recalling certain lots of GUNDRY Retrograde Cannula (Model 94113T), a cardiopulmonary bypass catheter, due to potential sterile barrier breach in the product.
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: FDA Class II recall involving a sterile barrier defect on an invasive surgical device where breach of sterility presents a risk of serious harm in a high-risk clinical setting, with no reported illnesses or injuries documented in the source text. This satisfies the High severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medtronic Perfusion Systems is recalling certain lots of the Medtronic GUNDRY Retrograde Cannula, Manual-Inflate, Silicone Body 13FR, Model 94113T, a cardiopulmonary bypass vascular catheter used in cardiac surgery. The recall affects 3,790 units distributed worldwide, including the United States and numerous international countries.
The recalled product has the potential for a sterile barrier breach. A sterile barrier breach can compromise the sterility of the device, which is critical for use in invasive surgical procedures where contamination could result in serious complications.
Affected lot numbers include: 0231651336, 0231651345, 0231651385, 0231651389, 0231651396, 0231667029, 0231667046, 0231757975, 0231758248, 0231758259, 0231936467, 0231982226, 0232274424, C232287618, C232287619, C232287620, C232598550, and C232598552.
Healthcare facilities and users of this product should immediately discontinue use of affected units and contact Medtronic Perfusion Systems for further instructions regarding return or replacement of recalled devices.
The recalled product
- Product
- Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; 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 (20)
- GTIN 00673978188447
- Lot Numbers: 0231651336
- GTIN 20643169454877
- 0231651345
- 0231651385
- 0231651389
- 0231651396
- 0231667029
- 0231667046
- 0231757975
- 0231758248
- 0231758259
- 0231936467
- 0231982226
- 0232274424
- C232287618
- C232287619
- C232287620
- C232598550
- C232598552.
Distribution
Distributed nationwide across the United States.