Z-0318-2022Class II

The Steripath Gen2 Blood Collection System Model Number/Description 2700-21-EN / Steripath Gen2 Blood...

Name: Z-0318-2022 The Steripath Gen2 Blood Collection System Model Number/Description 2700-21-EN / Steripath Gen2 Blood...
Creator: Magnolia Medical Technologies, Inc.
Published: 2021-11-02
License: https://open.fda.gov/license/

Magnolia Medical Technologies, Inc. / initiated 2021-11-02 / Terminated / root cause: manufacturing process

FDA source

Magnolia Medical Technologies, Inc. began a recall of The Steripath Gen2 Blood Collection System Model Number/Description 2700-21-EN / Steripath Gen2 Blood Collection System - 21G, Wide Neck 2700-23-EN / Steripath... on 2021-11-02. FDA classified it as Class II and gives the reason as "Due to an uptick of complaints associated with premature needle retraction of blood collection system". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0318-2022
Classification: Class II
Status: Terminated
Initiated: 2021-11-02
Posted: 2021-12-01
Terminated: 2023-05-08
Recalling firm: Magnolia Medical Technologies, Inc.
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
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Reason for recall: Due to an uptick of complaints associated with premature needle retraction of blood collection system.
Root cause tag: manufacturing process
FDA root cause: 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.
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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0318-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0318-2022	Class II	Terminated	Voluntary: Firm initiated	2021-12-08	2021-12-01

Product code JKA

K192247Class IISteripath Gen2 Blood Collection SystemMagnolia Medical Technologies, Inc. / cleared 2020-02-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)