ClearanceBrief
Recall Z-0318-2022 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

Magnolia Medical Technologies, Inc.

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

DateNov 2, 2021
StatusTerminated
ReasonDue to an uptick of complaints associated with premature needle retraction of blood collection system.
Root causeProcess control
ActionOn 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 Clinic
Quantity137,200 devices
DistributionU.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.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K192247Steripath Gen2 Blood Collection System
Magnolia Medical Technologies, Inc., Feb 28, 2020