Avanos Medical, Inc.: Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 198 Software Version: N/A Product Description: Ballard Closed Suction System for Neonates/Pediatr

Hazard

Lack of sterility assurance for closed suction catheter systems

Details from the source

Reason for recall: Lack of sterility assurance for closed suction catheter systems Distribution: Worldwide - US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, IA, IL, IN,KS, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and the countries of South Korea, New Zealand, Canada, Mexico, Germany, England, Slovenia, France, Austria, Guadalajara. Quantity: 1980 units Lot/code info: Lot Code: Lot/ Serial Number(s): 1561168 Each: 00609038938264 DSP: 10609038938261 Case: 20609038938268

UPC codes

00609038938264, 10609038938261, 20609038938268

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.