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FDA (Device enforcement)Recalled 2025-03-19class i

Avanos Medical, Inc.: Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 227-5 Software Version: N/A Product Description: Ballard Turbo-Cleaning Closed Suction System for

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: 1040 units Lot/code info: Lot Code: Lot/ Serial Number(s): 1555468 Each: 00609038989655 DSP: 10609038989652 Case: 20609038989659

UPC codes

00609038989655, 10609038989652, 20609038989659

Source

Official record: FDA (Device enforcement)

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

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