FDA Device recall Z-1660-2013
Custom Procedural Trays: Merit's Custom Angio Kits A custom procedural tray is a combination of legally marketed medical devices placed int…
- FDA Device
- Class II
- terminated
- Published 2013-07-10
On 2013-07-10 the FDA classified a Class II recall of Custom Procedural Trays: Merit's Custom Angio Kits A custom procedural tray is a combination of legally marketed medical devices placed int… by Merit Medical Systems, citing custom Procedural trays contain Medrad Hand Controller Sheaths which were recalled because the seal between the white polyethylene and the clear plastic may be missing on the pack….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1660-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-11-21 |
| Published | 2013-07-10 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Merit Medical Systems |
| Distribution | n/a |
Product
Custom Procedural Trays: Merit's Custom Angio Kits A custom procedural tray is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses. Contained within the tray are hand controller sheaths which are intended to enable increased flow control (when compared to hand injection) but with the feel of a hand syringe. It provides more control over the total volume delivered by allowing the physician to adjust contrast delivery during the injection and monitor total volume delivered to the patient.
Reason
Custom Procedural trays contain Medrad Hand Controller Sheaths which were recalled because the seal between the white polyethylene and the clear plastic may be missing on the package resulting in a potential breach of the sterility of this accessory.
Identifiers
| code_info | Merit's Custom Angio kits K09T-09812B and K09T-09812C, Lot numbers T252244, T318352, T342249, T359185 |
|---|
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-1660-2013%22
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