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U.S. Department of Health and Human Services

Class 2 Device Recall NonSterile and Sterile Procedural Trays

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 Class 2 Device Recall NonSterile and Sterile Procedural Trayssee related information
Date Initiated by FirmNovember 17, 2022
Date PostedJanuary 27, 2023
Recall Status1 Open3, Classified
Recall NumberZ-1030-2023
Recall Event ID 91387
Product Classification laparoscopy kit - Product Code FDE
ProductNon-sterile procedural trays labeled as LAPAROSCOPIC, 2 per case
Code Information Item Number: DYNJ900415L, UDI/GTIN Case: 40195327029426, UDI/GTIN Each: 10195327029425, Lot Numbers: 22HBO658, 22JBV699
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		Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile packaging.
FDA Determined
Cause 2		Device Design
ActionMedline Industries, LP notified consignees via email and first-class mail on 11/21/2022. Consignees were instructed to over-label the sterile kits with a warning label indicating Warning To Avoid Injury, Please Handle Blades with Care . For the Non-Sterile kits, they are to over label the affected kits indicating to remove the blades and replace from a different sterile supply. No product is to be returned. Customers were also instructed to complete and return the response form.
Quantity in Commerce260 cases (520 units)
DistributionUS Nationwide distribution in the states of AR, MD, WA, WI.
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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