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Angiodynamics, Inc. recalls ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T E
Recalled December 28, 2016 · FDA recall Z-0775-2017 · Angiodynamics
Hazard
Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the potential for the rotating luer to detach from the dilator hub during use. AngioDynamics has confirmed that affected sheath/dilators (Greatbatch Model Numbers 10904-001 and 10904-002) have been included in packaged AngioDynamics Stiffened Micro-Introducer Kits. · FDA Class III
Units
996 boxes
Sold at
Nationwide Distribution to AL, AR, CA, FL, GA, IL, KY, LA, MI, MN, MO, NC, OH, OK, SC, NY, ME, PA, MD, VA, WA, WI, WV, TN, and TX
Description
Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the potential for the rotating luer to detach from the dilator hub during use. AngioDynamics has confirmed that affected sheath/dilators (Greatbatch Model Numbers 10904-001 and 10904-002) have been included in packaged AngioDynamics Stiffened Micro-Introducer Kits.
Product
ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO B PG, Item Number H787065970515, Catalog No.REF 06597051, 2) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO S PG, Item Number H787065970535, Catalog No.REF 06597053, 3) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO A PG, Item Number H787065970555, Catalog No.REF 06597055 Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a small 21-gauge needle stick
Manufacturer(s)
Angiodynamics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →