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U.S. Department of Health and Human Services

Class 2 Device Recall Medline Probe Cover Kits

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 Class 2 Device Recall Medline Probe Cover Kitssee related information
Date Initiated by FirmMay 18, 2023
Date PostedJuly 20, 2023
Recall Status1 Open3, Classified
Recall NumberZ-2157-2023
Recall Event ID 92466
Product Classification Custom anesthesia tray - Product Code OGD
ProductMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: PEDIATRIC EP PACK, Model Number DYNJ45158A
Code Information all lots within expiry, distributed from Medline between December 2017 - May 2023: UDI/DI (EA) 10888277507210, UDI/DI (CS) 40888277507211
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		Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
FDA Determined
Cause 2		Device Design
ActionMedline distributed their recall notices to their consignees beginning on 05/18/2023 by letter. The notices explained the problem, and the risk and requested the destruction of the products. Distributors were directed to notify their consignees, have the customers document and destroy any affected product, and include your customers quantities on the response form. Beginning on 05/23/2023, Medline issued another notice to a separate group of consignees requesting that the kits be over labeled. Distributors were directed to notify the customers and have them return any affected product to the distributor for collection and return to Medline. Questions: please contact the Recall Department at 866-359-1704
Quantity in Commerce36 units
DistributionWorldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.
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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