A Medical Device Daily
The FDA has issued a nationwide alert warning concerning the use of all lots of preloaded syringes containing either heparin or sodium chloride intravenous catheter flushes manufactured by the IV Flush (Dallas) and distributed by Pinnacle Medical Supply (Rowlett, Texas).
The firm has voluntarily recalled the products because they lacked proper FDA market clearance, and the company also has been informed of Pseudomonas fluorescens (P. fluorescens) infections in patients possibly caused by the heparin flushes. P. fluorescens is an infrequent cause of infection but has been associated with outbreaks of pseudobacteremia — that is, the presence in a blood culture in the absence of clinical evidence of bloodstream infection.
P. fluorescens also has been reported as the cause of procedure-related infections and infections resulting from transfusion with contaminated blood components.
The cases are continuing to be investigated, according to the FDA.
The heparin and sodium chloride containing intravenous flushes were sold to distributors who then redistributed them to other distributors and hospitals. They can be identified by the syringe label, which reads, in part, “IV Flush Dallas, TX.“
IV Flush is notifying its distributors of the action and says those distributors should warn their customers. The company is arranging for return of all recalled products.
In a similar action, BD (Becton, Dickinson and Co.; Franklin Lakes, New Jersey) said it is voluntarily recalling certain lots of Urine Processing Kits, catalog #440454. This action includes notification to customers worldwide by telephone and by letter, the company said.
The Urine Processing Kit is designed to remove amplification inhibitors for testing urine specimens with Chlamydia trachomatis and Neisseria gonorrhoeae amplified DNA assays. These organisms are common causes of sexually transmitted infections in both men and women.
The recall was initiated on Jan. 10 after complaints were received by BD regarding an increased level of indeterminate results from urine specimens stored with a urine-processing pouch (UPP) at refrigerated temperatures. The impacted lots of UPPs were distributed between February and August 2004.
BD also said that it found an increased risk of false negative results if the Amplification Control was not used during testing. Patients with false negative results who were not treated for these sexually transmitted infections may either unknowingly remain infected or experience continued symptoms. In addition, there is an increased risk of transmitting these infections to unprotected sexual partners.
BD said “a root cause“ has been identified and that it has adopted additional quality inspection and testing to assure that all other products perform “acceptably.“
The lots were distributed in the U.S. and Europe, with smaller amounts distributed to Australia and Canada.
BD said it notified the FDA and other worldwide health agencies, “as necessary,“ to coordinate the recall.
BD manufactures and sells a broad range of medical supplies, devices, laboratory equipment and diagnostic products.
Cord Blood gets OK to trade on OTC Bulletin Board
Cord Blood America (Los Angeles) has commenced trading on the Nasdaq OTC Bulletin Board under the symbol CBAI.
Cord Blood America is the parent company of Cord Partners, which facilitates umbilical cord blood stem cell preservation for expectant parents and their children. Collected through a safe and non-invasive process, cord blood stem cells offer a powerful and life-saving resource for treating a growing number of ailments such as leukemia, anemia and certain types of cancers.
Founded in 2002 by Chairman and CEO Matthew Schissler, the company offers an integrated suite of services, from educational resources and straightforward collection to secure storage.