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
FDA Recall Z-0318-2022 · Posted None
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Recalling FirmMagnolia Medical Technologies, Inc.
Recall StatusTerminated
Product CodeJKA
Date Initiated2021-11-02
Date Terminated2023-05-08
Product Quantity137,200 devices
Reason for Recall
Due to an uptick of complaints associated with premature needle retraction of blood collection system.
Firm Action
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.
Root Cause
Process control
Distribution Pattern
U.S. Nationwide distribution in the states of MD, WV, DE, VA, DC, IN, MI, MA, SC, NY, IL, TX, AL, OK, GA, NE, FL, MO, CA, CO, NM, AR, WY, KS, PA, WA, MT, and AZ.
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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