FDA Medical Device Recalls (openFDA)
Magnolia Medical Technologies, Inc.: 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.
- Recall number
- Z-2393-2021
- Recalling firm
- Magnolia Medical Technologies, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2021-08-02
- Posted
- not on file
- Terminated
- 2023-02-22
- Reason
- Product was shipped with the incorrect Transfer Adapter Instructions For Use (IFU).
- Root cause
- Labeling Change Control
- Action
- On or about 08/02/2021, the firm hand delivered via its Clinical Team an "URGENT: MEDICAL DEVICE RECALL" Notification letter to customers informing them that a specific lot number of transfer adapters was shipped with the incorrect Instructions for Use. Customers are instructed to work with the Recalling Firm's Clinical Team member in identifying the affected products so that replacement Instructions for Use can be provided at no cost. Customers are also instructed to complete a Customer Acknowledgement Form, to record the quantity of affected products each customer has in their inventory and return to their local Recalling Firm's Clinical Team member, or directly to the Recalling Firm. For questions or assistance, contact Customer Service and Sales at 415-969-8183 or email kristine.delavega@magnolia-medical.com
- Quantity
- 9,400 units
- Distribution
- 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
- Lot, serial or model codes
- Catalog #: 27BD-EN, Part #: P00165-000 Lot #9448037
- 510(k) numbers
- ["K192247"]
- PMA numbers
- not on file
- Product code
- JKA
- Firm FEI
- 3009976527
- Firm city
- Seattle
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28