Recall Z-0420-2020 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Edwards Lifesciences, LLC
EZ Glide Aortic Cannula, 24 Fr. (8.0mm) x 37.6 cm (14.8") 3/8" (9.5 mm) vented connector , RX Only, Sterile EC, Made in Mexico, UDI: 00690103172119 for the following REF #s (UDI): EZC21A (00690103174182), EZC21TA (00690103174199), EZC24A (00690103714401), EZC24TA (00690103714418), EZF21A (00690103175080), EZF21TA (00690103175097), EZF24A (00690103175066), EZF24TA (00690103175073), EZS21A (0
| Date | Oct 22, 2019 |
| Status | Terminated |
| Reason | Their is a possibility that the cannula may separate from its connector, potentially causing a breach of circuit during cardiopulmonary bypass which could result in significant blood loss. |
| Root cause | Under Investigation by firm |
| Action | The firm plans to begin mailing a "urgent - Product Recall" notification on 10/22/2019 via FedEx Next Day Delivery. All recall notification letters should be mailed by 10/23/2019. The customer notification will request consignees take the following actions: 1. Review this field safety notice to understand the potential hazard, and return all unused inventory as instructed. 2. Complete and return the Product Reconciliation Form to Customer Service: a) Record the quantity of any affected EZ Glide aortic perfusion cannula in your possession, b) Segregate and quarantine affected product until |
| Quantity | 62,431 units |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Washington DC, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnes |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123370 | EZ GLIDE AORTIC CANNULA, AORTIC PERFUSION CANNULA WITH DURAFLO COATING, DISPERSION AORTIC PERFUSION CANNULA Edwards Lifesciences, LLC, Mar 13, 2013 |