Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010
Summary
The FDA issued a Class II for Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010 by Healthmark Industries Co., Inc.. Reason: During endoscope surveillance monitoring, a user facility identified contamination from duodenoscope samples that were linked to the Pre-filled Water .
Details
Source
Device Recall
External ID
Z-1909-2025
Action Date
2025-06-11
Status
Ongoing
Category
device
Product Description
Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010
Lot/Code Info: Lot Numbers: 200001 200002 200003 200004 200005 200006 200007 200008 200009 200010 200011 200012 200013
Quantity Affected: 250000 units
Reason for Recall
During endoscope surveillance monitoring, a user facility identified contamination from duodenoscope samples that were linked to the Pre-filled Water Syringes as part of their investigation. Healthmark Industries conducted its own investigation and concluded that the Pre-filled Water Syringe had been improperly used outside of the intended purpose.
Distribution
US Nationwide and Internationally to countries of: Canada, Malaysia.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-05-02
Company
Fraser, MI
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 165 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Healthmark Industries Co., Inc. has 3 FDA actions in our database, including 3 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 (Healthmark Industries Co., Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Healthmark Industries Co., Inc. have FDA actions?
Healthmark Industries Co., Inc. has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1909-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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