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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 PostedSeptember 06, 2024
Recall Status1 Open3, Classified
Recall NumberZ-3022-2024
Recall Event ID 94583
Product Classification Scissors, general, surgical - Product Code LRW
ProductMedline Convenience kits labeled as: SCS-LF, DYNJ902314D
Code Information DYNJ902314D, Lot Number 20FDA446 ; DYNJ902314D, Lot Number 20GDA480 ; DYNJ902314D, Lot Number 20IDA880 ; DYNJ902314D, Lot Number 20JDA187 ; DYNJ902314D, Lot Number 21CDA064 ; DYNJ902314D, Lot Number 21EDA709 ; DYNJ902314D, Lot Number 21EDA908 ; DYNJ902314D, Lot Number 21FDA451 ; DYNJ902314D, Lot Number 21FDB959 ; DYNJ902314D, Lot Number 21HDA759 ; DYNJ902314D, Lot Number 21IDC401 ; DYNJ902314D, Lot Number 21KDC395 ; DYNJ902314D, Lot Number 22CDA599 ; DYNJ902314D, Lot Number 22EDB585 ; DYNJ902314D, Lot Number 22IDA541 ; DYNJ902314D, Lot Number 22KDB745 ; DYNJ902314D, Lot Number 23BDA383 ; DYNJ902314D, Lot Number 23DDB444 ; DYNJ902314D, Lot Number 23EDA371
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 these 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 distribution.
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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