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Recall Observatory FDA recall evidence

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

August 02, 2021

Class II

Product summary

Firm
Magnolia Medical Technologies, Inc.
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

    reason.no_named_rule · v1.0.0

    Product was shipped with the incorrect Transfer Adapter Instructions For Use (IFU).