Avanos Medical, Inc.: Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 210 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: 4000 units Lot/code info: Lot Code: Lot/ Serial Number(s): 1561165 Each: 00609038938349 DSP: 10609038938346 Case: 20609038938343

UPC codes

00609038938349, 10609038938346, 20609038938343

Source

Official record: FDA (Device enforcement) ↗

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