The MEDRAD Twist & Go Disposable Syringe 150 mL with Quick Fill Tube is a syringe made from a clear polycarbonate materi
Summary
The FDA issued a Class II for The MEDRAD Twist & Go Disposable Syringe 150 mL with Quick Fill Tube is a syring by Bayer Medical Care, Inc.. Reason: Labeling error: MEDRAD Mark 7 Arterion Injection System Syringes (ART 700 SYR) labeled as Twist & Go Syringes (TAG 150 SYR).
Details
Source
Device Recall
External ID
Z-0199-2022
Action Date
2021-11-10
Status
Terminated
Category
device
Product Description
The MEDRAD Twist & Go Disposable Syringe 150 mL with Quick Fill Tube is a syringe made from a clear polycarbonate material and is an accessory to the MEDRAD Mark 7 Arterion Injection System. It is designed to be loaded into the injector head of the injection system.
Lot/Code Info: Batch number: 8415317
Quantity Affected: 6,950 units
Reason for Recall
Labeling error: MEDRAD Mark 7 Arterion Injection System Syringes (ART 700 SYR) labeled as Twist & Go Syringes (TAG 150 SYR)
Distribution
Worldwide distribution - US Nationwide and the countries of AU, BY, DE, DK, GB, HR, NL, NZ, RU, SE, TH.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-09-14
Company
Indianola, PA
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 120 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Bayer Medical Care, Inc. has 6 FDA actions in our database, including 3 recalls and 3 clearances.
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 (Bayer Medical Care, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Bayer Medical Care, Inc. have FDA actions?
Bayer Medical Care, Inc. has 6 FDA actions in our database, including 3 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0199-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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