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U.S. Department of Health and Human Services

Class 2 Device Recall Medline

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 Class 2 Device Recall Medlinesee related information
Date Initiated by FirmJanuary 04, 2024
Date PostedSeptember 30, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1157-2024
Recall Event ID 93795
Product Classification Syringe, irrigating (non dental) - Product Code KYZ
ProductMedline Contro-Bulb Syringe, REF DYND20125; bulb irrigation syringe
Code Information UDI/DI 40080196031765 (case), 10080196031764 (unit) Lot Numbers: 96922110001 and 96923100001
Recalling Firm/
Manufacturer		 MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information ContactKarin Johnson
886-359-1704
Manufacturer Reason
for Recall		Packaging material was updated for the Bulb Irrigation Syringe (DYND20125), and additional testing done at Medline Corporate indicated the potential for the sterile barrier to be breached during transportation. This only affects two lot numbers (96922110001 and 96923100001).
FDA Determined
Cause 2		Under Investigation by firm
ActionMedline Industries, LP issued an IMMEDIATE ACTION REQUIRED notice to its consignees on 01/04/2024 via USPS First Class. The notice explained the problem with the device, risk involved, and requested the consignee quarantine then destroy the affected product. Upon receipt of the completed destruction form, firm will issue credit, if applicable. Consignee was directed to notify all parties of this action to whom the product was distributed. For questions, contact 866-359-1704
Quantity in Commerce4831 units
DistributionUS, Nationwide
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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