Device product
AngioDynamics Micro Introducer Kits under the following labeling: 1) AngioDynamics 4F Standard Micro-Introducer Kit, Sterile, Catalog Number: 06597005, 2) AngioDynamics 5F Standard Micro-Introducer Kit, Sterile, Catalog number: 06597012; 3) AngioDynamics 4F Standard Micro-Introducer Kit, Sterile, Catalog Number: 06597013; 4) AngioDynamics 5F Standard Micro- Introducer Kit, Sterile, Catalog Number: 06597018; and 5) AngioDynamics 4F Standard Micro-Introducer Kit, Sterile, Catalog Number: 06597019. Product kits are individually wrapped in plastic, 10 units included per box. Product Usage: This device is intended to be used to measure the refractive power and the radius of corneal curvature of the human eye.
Z-1405-2013
Product summary
- Event
- Event 65119
- Status
- Terminated
- Classification
- Class II
- Quantity
- Domestic(1,760 units): 1)260 units/26 boxes, 2)310 units/31 boxes,3)260 units/26 boxes,4)880 units/88 boxes,5)60 units/6 boxes,Foreign:10 units/1 box
- Official record key
device-enforcement:Z-1405-2013
Official wording
Reason: AngioDynamics Inc., is recalling Micro Introducer Kits and VenaCure EVLT NeverTouch Procedure Kits, because the potential exists that the micro Introducer (sheath/dilator) packaged within the kit could be the incorrect French size.
Code information: Corresponding Lot numbers: 1) 588918 (Expiration date 01/2016), 2) 588927 (Expiration date 12/2015), 3) 588915 (Expiration date 01/2016), 4) 588913 (Expiration date 12/2015) and 5) 588930 (Expiration date 01/2016).
Distribution pattern: USA Nationwide Distribution including the states of: IL, GA, CA, NY OH, AZ, TX, NE, FL, PA, NC, WI, AL, IN, CO, MO, MT, NE, MA, VA, AK, IN, MI, NJ, MD, TN, CT, WA, MN
Derived failure modes
-
Unknown
AngioDynamics Inc., is recalling Micro Introducer Kits and VenaCure EVLT NeverTouch Procedure Kits, because the potential exists that the micro Introducer (sheath/dilator) packaged within the kit could be the incorrect French size.