Magnolia Medical Technologies, Inc. Recalls
Showing 1-2 of 2 recalls
The Steripath Gen2 Blood Collection System Model Number/Description 2700-21-EN / Steripath Gen2 Blood Collection System - 21G, Wide Neck 2700-23-EN / Steripath Gen2 Blood Collection System - 23G, Wide Neck 27BD-21-EN / Steripath Gen2 Blood Collection System - 21G, Long Neck 27BD-23-EN / Steripath Gen2 Blood Collection System - 23G, Long Neck
Due to an uptick of complaints associated with premature needle retraction of blood collection system.
On 11/02/2021, the Recalling Firm sent an "URGENT: MEDICAL DEVICE RECALL" Notification Letter to customers via email informing them that the firm has received a number of product complaints associated with its blood collecting systems where the retractable feature of the butterfly needles may prematurely activate. The product complaints have been associated with retractable feature being activated within the product packaging. Customers are instructed to: -Determine the quantity of the affected products remaining at their facility and communicated this to the Recalling Firm's Sales or Clinical team members. -The Recalling Firm will replace any of the affected products at no cost to the customer. -Notify all their staff of the recall and if the affected products have been further distributed, to contact/notify those customers/organization of this recall.
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 was shipped with the incorrect Transfer Adapter Instructions For Use (IFU).
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