| Class 2 Device Recall The Steripath Gen2 Blood Collection System | |
Date Initiated by Firm | November 02, 2021 |
Create Date | December 01, 2021 |
Recall Status1 |
Terminated 3 on May 08, 2023 |
Recall Number | Z-0318-2022 |
Recall Event ID |
88919 |
510(K)Number | K192247 |
Product Classification |
Tubes, vials, systems, serum separators, blood collection - Product Code JKA
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Product | 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 |
Code Information |
Model Number/Part Number/Description:
2700-21-EN/P00157-001/Steripath Gen2 Blood Collection System - 21G, Wide Neck
UDI Sales Pack: 10858366007013
UDI Sterile Pack: 00858366007016
Lot Numbers:
9447412
9447043
9446903
9447120
9446991
9447413
2700-23-EN/P00158-001/Steripath Gen2 Blood Collection System - 23G, Wide Neck
UDI Sales Pack: 10858366007020
UDI Sterile Pack: 00858366007023
Lot Numbers:
9446807
9447124
5005432
9446708
9447121
27BD-21-EN/P00166-000/Steripath Gen2 Blood Collection System - 21G, Long Neck
UDI Sales Pack: 10858366007037
UDI Sterile Pack: 00858366007030
Lot Numbers:
5005328
9446696
9446547
9446994
27BD-23-EN/P00167-000/Steripath Gen2 Blood Collection System - 23G, Long Neck
UDI Sales Pack: 10858366007044
UDI Sterile Pack: 00858366007047
Lot Numbers:
9447122 |
Recalling Firm/ Manufacturer |
Magnolia Medical Technologies, Inc. 200 W Mercer St Ste 500 Seattle WA 98119-5908
|
For Additional Information Contact | Kristine Dela Vega 415-969-8183 |
Manufacturer Reason for Recall | Due to an uptick of complaints associated with premature needle retraction of blood collection system. |
FDA Determined Cause 2 | Process control |
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.
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Quantity in Commerce | 137,200 devices |
Distribution | 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.
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Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = JKA
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