device · product 1 of 1
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 (00690103172096), EZS21TA (00690103172102), EZS24A (00690103172119), and EZS24TA (00690103172126) Product Usage: Aortic perfusion cannulae are intended for perfusion of the ascending aorta during short-term (< 6 hours) cardiopulmonary bypass procedures. Aortic cannulae in sizes 6 Fr. (2 mm) to 18 Fr. (6 mm) can be used in pediatric patient populations.
- Recall number
- Z-0420-2020
- Initiated
- October 22, 2019
- Classification
- Class II
- Status
- Terminated
- Recalling firm
- Edwards Lifesciences, LLC
- Quantity
- 62,431 units
App-derived interpretation
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.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Inspect official wording and provenance
Reason for recall
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.
Code information
Lot #s: 203876 207654 217024 226788,205724, 207655, 217025, 226938,205775, 208823, 217048, 227494,205868, 208893, 218185, 227886,205920, 208894, 218457, 228009,205921, 209901, 218539, 228259,205922, 209904, 219090, 228549,206369, 210110, 219212, 228558,206372, 210111, 219561, 229051,206373, 212032 ,220146 ,229054,206374, 212033 ,220151 ,229827,206768, 212034 ,220157 ,230690,206769, 212035 ,220802 ,230894,206770, 212258 ,220803 ,231105,206771, 212280 ,222841 ,231109,206772, 212959 ,222913 ,231111,206773, 213506 ,222914 ,231291,206774, 213914 ,222915 ,231485,206775, 214214 ,223174 ,232109,206776 ,214216 ,224233 ,232437,206777 ,214716 ,224235 ,234138,206778 ,214717 ,224662,207319 ,214961 ,224707,207320 ,215239 ,225306,207321 ,215495 ,225884,207322 ,216123 ,225885,207323 ,216196 ,226188,207324 ,216627 ,226596,207636 ,216628 ,226597,207638 ,216632, 226691
Distribution pattern
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, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Washington DC, Wisconsin, West Virginia, Wyoming and countries of Austria, Australia, Belgium, Bahrain, Canada, Switzerland, Chile, China, Cyprus, Czech Republic, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Hungary, Canary Islands, Ireland, India, Iceland, Italy, Japan, Mauritius, Malaysia, Netherlands, Norway, Poland, Romania, Sweden, Singapore, Slovakia, Thailand, Turkey, United Arab Emirates, South Africa.