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U.S. Department of Health and Human Services

Class 2 Device Recall MONOJECT SYRINGE

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 Class 2 Device Recall MONOJECT SYRINGEsee related information
Date Initiated by FirmDecember 15, 2022
Date PostedJanuary 11, 2023
Recall Status1 Open3, Classified
Recall NumberZ-0938-2023
Recall Event ID 91350
510(K)NumberK102969 
Product Classification Syringe, piston - Product Code FMF
ProductHCT 12 CC SYRINGE KIT, 20/TRAY,5 TRAYS/BAG, 5 BAGS /CASE HCT. Distributed by Health Care Technology.
Code Information Assembly Number HCT3548-2, UDI-DI: M752HCT354821, Lot Numbers: 222770947, 221809694, 221938965, 221748547, 221578546, 221808445, 221386002, 222859338, 222940522, 221938972
Recalling Firm/
Manufacturer		 Stradis Healthcare
3600 Burwood Dr
Waukegan IL 60085-8399
For Additional Information ContactTracy Melton
425-343-4613
Manufacturer Reason
for Recall		Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
FDA Determined
Cause 2		Process control
ActionStradis Healthcare notified consignees on about 12/15/2022 via email. The letter instructed consignees to examine inventory, immediately quarantine any affected product, contact Stradis Customer Care to arrange for return shipment of the recalled product, and to notify customers if the product was further distributed. Consignees were also asked to complete and return the Recall Acknowledgement Form.
Quantity in Commerce112,675 units
DistributionUS Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.
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.
510(K) Database510(K)s with Product Code = FMF
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