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Recall Observatory FDA recall evidence

Device product

Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2271418-5 Software Version: N/A Product Description: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI Component: N/A

Z-1526-2025

March 19, 2025

Class I

Product summary

Firm
Avanos Medical, Inc.
Event
Event 96528
Status
Ongoing
Classification
Class I
Quantity
1420 units
Official record key
device-enforcement:Z-1526-2025

Official wording

Reason: Lack of sterility assurance for closed suction catheter systems

Code information: Lot Code: Lot/ Serial Number(s): 1555430 Each: 00609038982632 DSP: 10609038982639 Case: 20609038982636

Distribution pattern: 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.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of sterility