FDA Device recall Z-1405-2013
AngioDynamics Micro Introducer Kits under the following labeling: 1) AngioDynamics 4F Standard Micro-Introducer Kit, Sterile, Catalog Numbe…
- FDA Device
- Class II
- terminated
- Published 2013-06-05
On 2013-06-05 the FDA classified a Class II recall of AngioDynamics Micro Introducer Kits under the following labeling: 1) AngioDynamics 4F Standard Micro-Introducer Kit, Sterile, Catalog Numbe… by Angiodynamics, citing angioDynamics Inc., is recalling Micro Introducer Kits and VenaCure EVLT NeverTouch Procedure Kits, because the potential exists that the micro Introducer (sheath/dilator) package….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1405-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-04-30 |
| Published | 2013-06-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Angiodynamics |
| Distribution | US |
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.
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.
Identifiers
| code_info | Corresponding Lot numbers: 1) 588918 (Expiration date 01/2016), 2) 588927 (Expiration date 12/2015), 3) 588915 (Expirat…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). |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1405-2013%22
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