Power Injectable CT Port insertion kits - Product Usage: is an implantable access device designed to provide repeated access to the vascular system.
Check against the official notice below — it lists the full affected range.
Medical Components, Inc is recalling certain 5F Dignity CT Port insertion kits that were packaged with incorrectly sized ports. The kits contain 6.6F ports instead of the correct 5F ports, which prevents the catheter lumen from connecting properly to the port stem. This incompatibility may not be discovered until well into the surgical insertion procedure, after the catheter has already been placed in the blood vessel, at which point an alternate port must be obtained. The recall affects 96 pieces (with an additional 72 pieces identified later) distributed nationwide across California, DC, Georgia, Illinois, Indiana, Massachusetts, Michigan, New Jersey, New Mexico, New York, Ohio, Pennsylvania, and Texas, with specific lot numbers MPDX180 and MPCY660.
A prolonged insertion procedure to obtain and use an alternate port increases the risks associated with surgical procedures. The product recall record does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
The 5F Dignity CT Port kits were packaged with the incorrect size port. The kits include a 6.6F port instead of the correct 5F port. The inability to connect the catheter lumen to the port stem because of the incorrect size may not be noted until well into the procedure, after the catheter lumen is placed in the vessel. An alternate port will need to be obtained prolonging the procedure. A prolonged insertion procedure increases any risk associated with a surgical procedure.
Reason for recall: The 5F Dignity CT Port kits were packaged with the incorrect size port. The kits include a 6.6F port instead of the correct 5F port. The inability to connect the catheter lumen to the port stem because of the incorrect size may not be noted until well into the procedure, after the catheter lumen is placed in the vessel. An alternate port will need to be obtained prolonging the procedure. A prolonged insertion procedure increases any risk associated with a surgical procedure. Distribution: US Nationwide distribution in the states of CA, DC, GA, IL, IN, MA, MI, NJ, NM, NY, OH, PA, TX. Updated 3/11/2021 Quantity: 96 pieces total (updated 3/11/2021 additional 72 pieces) Lot/code info: Catalog Number: MRDP50AXS, Lot Number: MPDX180, UDI Number: 884908149753 (updated 3/11/2021 added lot number: MPCY660)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.