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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-3013-2024
Recall Event ID 94583
Product Classification Tray, irrigation, sterile - Product Code EYN
ProductMedline Convenience kits labeled as: 1) CYSTO PACK, Pack Number DYNJ42742D; 2) CYSTO PACK, Pack Number DYNJ42799
Code Information DYNJ42742D , Lot Number 19ABF928 ; DYNJ42742D , Lot Number 19BBC938 ; DYNJ42742D , Lot Number 19PBB060 ; DYNJ42742D , Lot Number 19GBO530 ; DYNJ42742D , Lot Number 19HBH965 ; DYNJ42742D , Lot Number 19HBJ692 ; DYNJ42799, Lot Number 21GBH529 ; DYNJ42799, Lot Number 19CBO493 ; DYNJ42799, Lot Number 19EBF614 ; DYNJ42799, Lot Number 19FBD772 ; DYNJ42799, Lot Number 19GBE887 ; DYNJ42799, Lot Number 19HBI404 ; DYNJ42799, Lot Number 19IBT472 ; DYNJ42799, Lot Number 20ABD578 ; DYNJ42799, Lot Number 20CBF124 ; DYNJ42799, Lot Number 20DBC424 ; DYNJ42799, Lot Number 20EBT962 ; DYNJ42799, Lot Number 20JBF487 ; DYNJ42799, Lot Number 20JBZ120 ; DYNJ42799, Lot Number 21ABV059 ; DYNJ42799, Lot Number 21BBM615 ; DYNJ42799, Lot Number 21EBP168 ; DYNJ42799, Lot Number 21EBP171
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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