Recall Z-2393-2021 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
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.
| Date | Aug 2, 2021 |
| Status | Terminated |
| 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 an |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K192247 | Steripath Gen2 Blood Collection System Magnolia Medical Technologies, Inc., Feb 28, 2020 |