FDAOctober 22, 2019device
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 (0069010...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
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UPCs
006901031721190069010317418200690103174199006901037144010069010371441800690103175080006901031750970069010317506600690103175073006901031720960069010317210200690103172126
Recall history
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- FDACytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710.2026-03-19
- FDACytal Burn Matrix 7x10 cm. Product ID: BMM0710.2026-03-19
- FDACytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.2026-03-19
- FDACUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system.2026-03-06
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