Device 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.
Z-1660-2013
Product summary
- Event
- Event 64078
- Status
- Terminated
- Classification
- Class II
- Quantity
- 134 trays
- Official record key
device-enforcement:Z-1660-2013
Official wording
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.
Code information: Merit's Custom Angio kits K09T-09812B and K09T-09812C, Lot numbers T252244, T318352, T342249, T359185
Distribution pattern: U.S. Military Hospital on base in Landstuhl, Germany
Derived failure modes
-
Sterility assurance
package resulting in a potential breach of the sterility