Z-2393-2021Class II

Steripath Luer Transport Pack, Gen2, Luer, BD -

Name: Z-2393-2021 Steripath Luer Transport Pack, Gen2, Luer, BD -
Creator: Magnolia Medical Technologies, Inc.
Published: 2021-08-02
License: https://open.fda.gov/license/

Magnolia Medical Technologies, Inc. / initiated 2021-08-02 / Terminated / root cause: labeling and UDI

FDA source

Magnolia Medical Technologies, Inc. began a recall of 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... on 2021-08-02. FDA classified it as Class II and gives the reason as "Product was shipped with the incorrect Transfer Adapter Instructions For Use (IFU)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2393-2021
Classification: Class II
Status: Terminated
Initiated: 2021-08-02
Posted: 2021-08-31
Terminated: 2023-02-22
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.
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Reason for recall: Product was shipped with the incorrect Transfer Adapter Instructions For Use (IFU).
Root cause tag: labeling and UDI
FDA 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 [email protected]
Quantity in commerce: 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
Product codes and lots: Catalog #: 27BD-EN, Part #: P00165-000 Lot #9448037

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2393-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2393-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-08	2021-08-31

Product code JKA

K192247Class IISteripath Gen2 Blood Collection SystemMagnolia Medical Technologies, Inc. / cleared 2020-02-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)