Medical Components Inc

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.

The 9.6F port kits were packaged with the incorrect valved peelable introducer. The label states the kit contains a 10F valved peelable introducer. The kit is packaged with a 9F valved peelable introducer. The port lumen will not fit through the introducer during the insertion procedure.

This recall has been initiated due to the product labeled with the incorrect expiration date.

The dual port with catheters was not covered under FDA clearance.

Medcomp has initiated the recall of Duo-Flow 400XL Catheter, Hemo-Flow Catheter, SLX Catheter, Triple Lumen Infusion Catheter, CT rated PICC, Split Cath III, PC Split Cath III because the product shipped was out of specification. One BI (biological indicator) out of 21 on the sterilization load was out of specification.

Drug products contained within the kits may have been rendered ineffective by a duplicate sterilization process. The kits include one or more of the following drugs: 5ml ampule of lidocaine, 3ml Chloraprep one-step, 10ml pre-filled saline syringe, Hygea saline wipes, and 3ml tinted Chloraprep. No injuries or illnesses were reported.

The Split Cath III Trays were incorrectly labeled as 16F x 32CM Split Cath III instead of 28CM.

The affected product was packaged with the incorrect introducer needle. The kit label indicates a "safety" needle is included; the kits were packaged with a non-safety needle.

Product was packaged with the incorrect port and does not match the label. The kit is labeled as an 8F Low Profile Pro-Fuse CT Port. The kit contains an 8F Midsize Dignity CT Port.

50 trays of Dignity Low Profile CT Port were labeled as Dignity Mid-Sized CT Port.