Avanos Medical, Inc.: Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 220135 Software Version: N/A Product Description: Ballard Closed Suction System for Adults, 14 F,

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: 9020 units Lot/code info: Lot Code: Lot/ Serial Number(s): 1555453, 1564227 Each: 00609038944920 DSP: 10609038944927 Case: 20609038944924

UPC codes

00609038944920, 10609038944927, 20609038944924

Source

Official record: FDA (Device enforcement) ↗

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