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U.S. Department of Health and Human Services

Class 2 Device Recall Medline Sterile Piston Irrigation Syringe Tray with Saline

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 Class 2 Device Recall Medline Sterile Piston Irrigation Syringe Tray with Salinesee related information
Date Initiated by FirmAugust 09, 2019
Create DateAugust 23, 2019
Recall Status1 Open3, Classified
Recall NumberZ-2358-2019
Recall Event ID 83551
Product Classification Tray, irrigation, sterile - Product Code EYN
ProductMedline SYRINGE, PISTON,IRR TRAY,W/.9, REF DYNC2303. Sterile Piston Irrigation Syringe Tray with Saline
Code Information Lot Number 19CAB954
FEI Number 1417592
Recalling Firm/
Manufacturer		 Medline Industries Inc
Three Lakes Drive
Northfield IL 60093
For Additional Information ContactBenjamin Gora
866-359-1704
Manufacturer Reason
for Recall		Samples in the identified lot were found to have incomplete or open packaging seals.
FDA Determined
Cause 2		Under Investigation by firm
ActionConsignees were notified via first class mail on August 9, 2019. The letter requested the following: 1. Immediately check your stock for item number DYNC2303 and the affected lot number, 19CAB954. Quarantine all affected product. Destroy all product belonging to the affected lot numbers listed on the destruction form. 2. Please return the completed enclosed response form listing the quantity of affected product destroyed. Even if you do not have any affected product please complete and return the form as indicated. When we receive your completed destruction form your account will be issued a credit, if applicable. 3. If you have transferred possession of this product to another individual, to another department or another location in your organization you are required by FDA regulations to notify them of this recall communication.
Quantity in Commerce11962 trays
DistributionUS nationwide distribution
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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