Z-2393-2021 Class II Terminated

Recalled by Magnolia Medical Technologies, Inc. — Seattle, WA

FDA device recall Z-2393-2021 was initiated by Magnolia Medical Technologies, Inc. on August 2, 2021 and is designated Class II. Reason for recall: Product was shipped with the incorrect Transfer Adapter Instructions For Use (IFU). The recall status is terminated (terminated February 22, 2023). Affected quantity: 9,400 units.

Recall Details

Product Type
Devices
Report Date
September 8, 2021
Initiation Date
August 2, 2021
Termination Date
February 22, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
9,400 units

Product Description

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.

Reason for Recall

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

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

Code Information

Catalog #: 27BD-EN, Part #: P00165-000 Lot #9448037