Smiths Medical ASD, Inc. Portex ProVent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Lots of Smiths Medical Portex Pro-Vent and LineDraw Arterial Blood Sampling syringes may have broken luers.

Recommended Action

Per FDA guidance

The firm initiated the recall by letter on January 07, 2020. The "Urgent Medical Device Recall Notice", identified the removal of devices and instructed the customer to quarantine the affected products. The Notice provided the accompanying Recall Response Form to be completed and returned within 10 days of receipt to smithmedical4136@stericycle.com. The Notice details that the affected product must be returned to Stericycle for processing. The Notice instructed the distributor to notify their customers and to provide the customer a copy of the Recall Notice and Response Form. The Notice provided the contact email smithmedical4136@stericycle.com and phone number of 8669188738 for assistance.

Distribution

As reported by FDA

AL, AZ, AR, CA, CO, DE, FL, GA, ID, IL, IN, IA, KS, LA, MD, MA, MI, MN, MS, MO, NE, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA