Device product
Steripath Luer Transport Pack, Gen2, Luer, BD - Product Usage: This holder/adapter assembly may be used for the access of a specimen from Catheter Port to BD Vacutainer¿ Blood Collection or Urine Collection Tubes.
Z-2393-2021
Product summary
- Event
- Event 88338
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9,400 units
- Official record key
device-enforcement:Z-2393-2021
Official wording
Reason: Product was shipped with the incorrect Transfer Adapter Instructions For Use (IFU).
Code information: Catalog #: 27BD-EN, Part #: P00165-000 Lot #9448037
Distribution pattern: U.S. Nationwide distribution i the states of AL, CO, FL, GA, IL, IN, MD, MI, NE, NY, PA, SC, TX, VA, WV, and WY. O.U.S.: N/A
Derived failure modes
-
Unknown
Product was shipped with the incorrect Transfer Adapter Instructions For Use (IFU).