Device product
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 Adults, 14 F, DSE Component: N/A
Z-1527-2025
Product summary
- Event
- Event 96528
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 1040 units
- Official record key
device-enforcement:Z-1527-2025
Official wording
Reason: Lack of sterility assurance for closed suction catheter systems
Code information: Lot Code: Lot/ Serial Number(s): 1555468 Each: 00609038989655 DSP: 10609038989652 Case: 20609038989659
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
Lack of sterility