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.
FDA Recall Z-2393-2021 · Posted None
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Recalling FirmMagnolia Medical Technologies, Inc.
Recall StatusTerminated
Product CodeJKA
Date Initiated2021-08-02
Date Terminated2023-02-22
Product Quantity9,400 units
Reason for Recall
Product was shipped with the incorrect Transfer Adapter Instructions For Use (IFU).
Firm 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]
Root Cause
Labeling Change Control
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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