Steripath Luer Transport Pack, Gen2, Luer, BD - Product Usage: This holder/adapter assembly may be used for the access o
Summary
The FDA issued a Class II for Steripath Luer Transport Pack, Gen2, Luer, BD - Product Usage: This holder/adapt by Magnolia Medical Technologies, Inc.. Reason: Product was shipped with the incorrect Transfer Adapter Instructions For Use (IFU)..
Details
Source
Device Recall
External ID
Z-2393-2021
Action Date
2021-09-08
Status
Terminated
Category
device
Product Description
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.
Lot/Code Info: Catalog #: 27BD-EN, Part #: P00165-000 Lot #9448037
Quantity Affected: 9,400 units
Reason for Recall
Product was shipped with the incorrect Transfer Adapter Instructions For Use (IFU).
Distribution
U.S. Nationwide distribution i the states of AL, CO, FL, GA, IL, IN, MD, MI, NE, NY, PA, SC, TX, VA, WV, and WY. O.U.S.: N/A
Type: Voluntary: Firm initiated
Recall Initiated: 2021-08-02
Company
Seattle, WA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 126 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Magnolia Medical Technologies, Inc. has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Magnolia Medical Technologies, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Magnolia Medical Technologies, Inc. have FDA actions?
Magnolia Medical Technologies, Inc. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2393-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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