Merit Medical Systems, Inc.: Medical Device Recall in 2013 - (Recall #: Z-1660-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: November 21, 2012

Date Posted: July 10, 2013

Recall Number: Z-1660-2013

Event ID: 64078

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.

Status: Terminated

Product Quantity: 134 trays

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

Voluntary or Mandated:

Voluntary: Firm initiated