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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 FirmFebruary 11, 2025
Date PostedMarch 25, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1450-2025
Recall Event ID 96374
Product Classification Obstetrical kit - Product Code OKV
ProductMedline procedure kits labeled as: 1) L S GYN PACK, Pack Number DYNJ65616C; 2) MAIN CYSTO, Pack Number DYNJ61371A; 3) OB PACK-LF, Pack Number DYNJ20720C; 4) PELVISCOPY PACK-LF, Pack Number DYNJ0415776N; 5) POSTERIOR EYE PACK-LF, Pack Number PHS656483I; 6) ROBOTICS PACK-LF, Pack Number DYNJ0046667A
Code Information 1) Pack Number DYNJ65616C: UDI/DI 10195327470869 (each) 40195327470860 (case), Lot Number 23LMF217A; 2) Pack Number DYNJ61371A: UDI/DI 10193489796803 (each) 40193489796804 (case), Lot Number 21FMA140A; 3) Pack Number DYNJ20720C: UDI/DI 10884389620564 (each) 40884389620565 (case), Lot Number 21EMF438A; 4) Pack Number DYNJ0415776N: UDI/DI 10193489413984 (each) 40193489413985 (case), Lot Number 22CMD073A; 5) Pack Number PHS656483I: UDI/DI 10889942806768 (each) 40889942806769 (case), Lot Number 23GMB728A; 6) Pack Number DYNJ0046667A: UDI/DI 10889942160396 (each) 40889942160397 (case), Lot Number 22CMD979A
FEI Number 1417592
Recalling Firm/
Manufacturer		 MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information ContactHaley Barclay
866-359-1704
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 02/11/2025 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. This is an expansion of RES 94583
Quantity in Commerce570 units
DistributionWorldwide distribution - US Nationwide and the country of Canada.
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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