Custom Procedural Trays: Merit's Custom Angio Kits A custom… — Class II medical device recall Z-1660-2013
Terminated recall by Merit Medical Systems, Inc., reported 2013-07-10. Custom Procedural trays contain Medrad Hand Controller Sheaths which were recalled because the seal between th
| Recall number | Z-1660-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merit Medical Systems, Inc., Chester, VA, United States |
| Recall initiated | 2012-11-21 |
| Classified | 2013-07-03 |
| Reported by FDA | 2013-07-10 |
| Terminated | 2013-07-12 |
| Countries outside the US | DE |
| Quantity | 134 trays |
| Reason classes | sterility, packaging |
| Lot numbers | T252244, T318352, T342249, T359185 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1660-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.