FDA Device

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.

Hazard

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

What You Should Do

Remedy

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

Products

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 Colle
Brand
Magnolia Medical Technologies, Inc.
UPC
Catalog #: 27BD-EN, Part #: P00165-000 Lot #9448037

Units Affected

9,400 units