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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 FirmApril 08, 2024
Date PostedAugust 28, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2755-2024
Recall Event ID 94581
Product Classification Dressing change tray - Product Code OXQ
ProductMedline procedural kits labeled as: 1) CIRCUMCISION TRAY, Pack Number CIT6715; 2) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920; 3) PORT DRESSING CHANGE TRAY, Pack Number DT18415; 4) UCLA - BREAST BIOPSY KIT, Pack Number DYNDH1512
Code Information CIT6715, Lot Number 2023011090; CIT6920, Lot Number 2021081890; DT18415 , Lot Number 22OBA722 ; DT18415 , Lot Number 22JBQ737 ; DT18415 , Lot Number 23BBE570 ; DT18415 , Lot Number 23DBS680 ; DT18415 , Lot Number 23EBS516 ; DT18415 , Lot Number 23HBN856 ; DT18415 , Lot Number 23JBV086 ; DT18415 , Lot Number 21BBF570 ; DT18415 , Lot Number 21CBO659 ; DT18415 , Lot Number 24CBM583 ; DYNDH1512, Lot Number 2021120690
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		Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
FDA Determined
Cause 2		Under Investigation by firm
ActionMedline Industries LP issued a recall notice to its consignees on 04/08/2024 via letter delivered via USPS and email. The notice explained the issue, provided a link to for information pertaining to the risk involved https://www.fda.gov/medical-devices/safety-communications/update-evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication) and request the syringes within the convenience be discarded, except for circumstances where no alternative syringes are readily available. If these syringes must be used, closely monitor for leaks, breakage, and any other problems, and report any quality issues to Medline and the FDA. Distributors were directed to notify their customers. The firm issued a second recall notice (an expansion) on 05/02/2024 using the same methods.
DistributionWorldwide
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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