Mavidon—PediaPrep Tubes and PediaPrep Single-Use Cups: May Be Contaminated with Burkholderia cepacia
October 23, 2019 | Risk Management News
ECRI Institute's complete weekly summary of medical device hazard and recall information is available in ECRI Institute's Health Device Alerts. For more information contact us at email@example.com.
In an October 6, 2019, Medical Device Recall letter submitted by an ECRI Institute member hospital, Mavidon states that the above products may be contaminated with Burkholderia cepacia (B. cepacia), a multi-drug resistant pathogenic microorganism. Contaminated products with B. cepacia can result in serious, life-threatening infections in patients with compromised immune systems, such as neonates, elderly patients, pregnant women, and cancer patients, but also in previously healthy individuals. Mavidon also states that it was notified on August 2, 2019, that 114 gm tubes of LemonPrep were tested and found to be contaminated with B. cepacia. PediaPrep tubes and PediaPrep single-use cups were manufactured around the same time and using some of the same raw materials as LemonPrep. Mavidon further states that it is testing all lots (or retains) of PediaPrep manufactured since September 2017 to find out whether B. cepacia contaminated other products. Mavidon states that it has received no reports of adverse events associated with affected product. The manufacturer has not confirmed the...