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U.S. Department of Health and Human Services

Class 2 Device Recall Custom Sterile and NonSterile Procedural Kits containing Turkuaz Ultrasound Gel

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 Class 2 Device Recall Custom Sterile and NonSterile Procedural Kits containing Turkuaz Ultrasound Gelsee related information
Date Initiated by FirmMay 15, 2023
Date PostedAugust 03, 2023
Recall Status1 Open3, Classified
Recall NumberZ-2330-2023
Recall Event ID 92399
Product Classification Patient personal hygiene kit - Product Code NSB
ProductCustom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. KIT TRIAGE ADMIT, Model Number: DYKA1456; b. KIT,ANTE PARTUM, Model Number: DYKL1844; c. MATERNAL ADMIT KIT, Model Number: DYKM2091
Code Information All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYKA1456, UPC Number: 019532723188. b. Model Number: DYKL1844, UPC Number: 019532723181. c. Model Number: DYKM2091, UPC Number: 019348998356.
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 the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionMedline notified customers beginning on 05/15/2023, via mail and email with letter. Customers with Medline Probe Cover Kits were instructed to check inventory for affected kits, destroy any affected kits, and complete and return the response form. Distributors were instructed to notify their customers and have them document and destroy affected kits. Customers with the non-sterile and sterile procedural kits were instructed to quarantine kits, complete and return the response form and, once updated labels are received, over label and discard the affected ultrasound gel product within the kits. Distributors were instructed to notify customers of the recall and have customers return any affected product for return to Medline. Medline identified additional units of Medline Probe Cover Kits and notified customers on 06/22/2023. Customers were instructed to quarantine kits, complete and return the response form and, once updated labels are received, over label and discard the affected ultrasound gel product within the kits.
Quantity in Commerce7,040 kits
DistributionWorldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.
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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