Deltec, Inc Recalls

FDA
4
Total Recalls
1
Agencies
Jul 2004
First Recall
Dec 2006
Latest Recall
Sort: Newest first Highest severity

Showing 1-4 of 4 recalls

FDA

Port-A-Cath II Low Profile Epidural Implantable Access System, with PolyFlow Polyurethane Catheter, 1.2mm O.D. x 0.5mm I.D., REF 21-1501-01

Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization.

A recall letter dated March 26, 2004 gave customers the option of returning the products or using the products if the customer's procedures do not require sterility of the outer surface of the inner tray.
FDA

Deltec CADD-Prizm PCS II Ambulatory Infusion Pump with Revision E Software

Pump keyboard entries by the patient could have resulted in the patient having unintended access to programming screens and led to in improper drug dosage.

A recall letter, sent to the consignees on June 23, stated that the firm would telephone the consignees to arrange the correction of their affected pumps by reprogramming with the new software.
FDA

Deltec Cozmo Insulin Pump, Model 1700, Product Catalog Numbers 21-1711-01, 21-1712-01 and 21-1713-01. The 3 versions vary only in the color of the exterior.

A software error could have resulted in the delivery of a larger bolus of insulin than anticipated when the pump was programmed in a particular manner.

Recall Notification letters were sent to the consignees on March 14, 2003. The letters gave recommendations for avoiding the problem, stated that updated software to prevent the problem would be introduced, and requested that the customer call a toll-free phone number to arrange replacement of their affected pump.
FDA

Ventra Percutaneous Intravenous Catheter Repair Kit for Luer Connector Segments and Single-Lumen Catheters, Reorder Number 21-0105

Silicone adhesive in kits used to repair damaged catheters did not set (cure) properly and remained in a tacky state.

A recall letter, sent to the consignees on July 8, 2003, gave them the option of returning the kits or waiting for the firm to provide them with replacement silicone adhesive.