About PICC Lines from VAM

Specializing in all aspects of:
Peripherally
Inserted
C
entral
Catheters

A Second Heparin Recall

 

A second recall was announced on January 25, 2008 on prefilled heparin and saline syringes that have been manufactured by AM2 PAT, Inc and distributed with brand names of Sierra Pre filled Inc and B. Braun. The U.S. Food and Drug Administration (FDA) reported that the two types of flushes were found to be contaminated with Serratia Marcescens which is a bacterium most commonly found in water and soil.

The first recall for the same manufacture came December 20, 2007 with the same contaminate. The FDA investigated the facility where the syringes were manufactured and found that the facility was not compliant with the Quality System regulations to ensure sterility of the syringes.

The syringes are dispensed in 3ml, 5ml and 10ml fill in 6ml and 12ml syringe sizes. These syringes are typically used for the care and maintenance of vascular access devices such as PICC Lines, triple lumen central lines, medaports and peripheral IVs.

If you are maintaining your vascular access device at home or work in a facility that utilizes pre-filled syringes it is recommended that you check the type of syringe and its manufacture. If using the syringe distributed by the above the FDA recommends the stop of use immediately, quarantine the product, and notify health care provider or Administrator.

An associated web site is www.fda.gov/medwatch.

References

(1) http: www.fda.gov, FDA News; FDA Warns Public of Contaminate Syringes (AM2 PAT, Inc., issues nationwide recall of pre-filled syringe flush.

 

The consumer health information on this Website is for informational and educational purposes only and is not a substitute for medical advice or treatment for any medical conditions.