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U.S. Department of Health and Human Services

Class 2 Device Recall Prefilled Water Syringe

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 Class 2 Device Recall Prefilled Water Syringesee related information
Date Initiated by FirmMay 02, 2025
Date PostedJune 05, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1909-2025
Recall Event ID 96823
Product Classification Pre-filled Water Syringe - Product Code MNL
ProductPre-filled Water Syringe, Model Numbers SW-010-100 and SW-010
Code Information Lot Numbers: 200001 200002 200003 200004 200005 200006 200007 200008 200009 200010 200011 200012 200013
Recalling Firm/
Manufacturer		 Healthmark Industries Co., Inc.
18600 Malyn Blvd
Fraser MI 48026-3496
Manufacturer 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.
FDA Determined
Cause 2		Under Investigation by firm
ActionAn "URGENT PRODUCT RECALL" notification letter was sent to customers beginning 5/2/25. Recommended Mitigations/ User Recommendations Please discontinue use of the Pre-Filled Water Syringes containing non-sterile water, which can be identified by a red cap. Any unused product can be returned for credit or replacement. Customer are requested to take the following actions 1. Ensure all affected product in your facility s inventory is no longer in use and has been properly quarantined. 2. Please ensure this message is forwarded to any individuals that need notification within your organization or any organization where the affected products have been transferred. 3. Contact Customer Service via email at HMCS@hmark.com or 800-521-6224 to return your unused affected product or if you have any questions. 4. Complete and return the response form Getinge by e-mailing a copy to recallresponses.qrc@getinge.com.
Quantity in Commerce250000 units
DistributionUS Nationwide and Internationally to countries of: Canada, Malaysia.
Total Product Life CycleTPLC Device Report
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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