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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-3040-2024
Recall Event ID 94583
Product Classification Chest drainage kit - Product Code PAD
ProductMedline Convenience kits labeled as: 1) CHEST TUBE TRAY , Pack Number CHT2120; 2) CHEST TUBE INSERTION TRAY , Pack Number DYNDA2475; 3) CHEST TUBE INSERTION TRAY , Pack Number DYNDA2941A ; 4) PERICARDIAL DRAIN KIT , Pack Number DYNDA2998; 5) KIT, BEDSIDE THORACENTESIS SFT, Pack Number DYNDH1794; 6) KIT, BEDSIDE THORACENTESIS SFT, Pack Number DYNDH1794H ; 7) CHEST TUBE INSERTION PACK , Pack Number DYNJ04474F ; 8) DRAINAGE FOR GRAPEVINE PACK , Pack Number DYNJ66222B ; 9) DRAINAGE PACK , Pack Number DYNJ67988A ; 10) CHEST/BREAST-LF , Pack Number DYNJ83950; 11) IR DRAIN PACK , Pack Number DYNJ85264; 12) INCISION AND DRAINAGE , Pack Number DYNJ904606C; 13) I&D TRAY, Pack Number MNS15250
Code Information CHT2120, Lot Number 23DLA374 ; CHT2120, Lot Number 23ELA871 ; CHT2120, Lot Number 23FLA655 ; DYNDA2475, Lot Number 22IMA813 ; DYNDA2941A , Lot Number 23BMB940 ; DYNDA2941A , Lot Number 23FMF503 ; DYNDA2998, Lot Number 22KBB005 ; DYNDA2998, Lot Number 23BBD525 ; DYNDH1794, Lot Number 22LBM374 ; DYNDH1794, Lot Number 23EBL615 ; DYNDH1794, Lot Number 23LMF847 ; DYNDH1794H , Lot Number 23LMF847 ; DYNDH1794H , Lot Number 22LBM374 ; DYNDH1794H , Lot Number 23EBL615 ; DYNJ04474F , Lot Number 22JLA750 ; DYNJ04474F , Lot Number 23BLA545 ; DYNJ04474F , Lot Number 23FLA171 ; DYNJ66222B , Lot Number 24ALA413 ; DYNJ66222B , Lot Number 24ALA509 ; DYNJ66222B , Lot Number 24CLA156 ; DYNJ67988A , Lot Number 22JMG867 ; DYNJ67988A , Lot Number 22LMI605 ; DYNJ67988A , Lot Number 23AMJ359 ; DYNJ67988A , Lot Number 23DMG616 ; DYNJ67988A , Lot Number 23EMI610 ; DYNJ67988A , Lot Number 23GMB085 ; DYNJ67988A , Lot Number 23IMH819 ; DYNJ67988A , Lot Number 23KMF739 ; DYNJ83950, Lot Number 23CBG610 ; DYNJ83950, Lot Number 23FBF248 ; DYNJ83950, Lot Number 23LBR075 ; DYNJ85264, Lot Number 23KBE782 ; DYNJ904606C, Lot Number 23HBP402 ; DYNJ904606C, Lot Number 23IBS124 ; DYNJ904606C, Lot Number 23JBN042 ; DYNJ904606C, Lot Number 23KBW145 ; MNS15250 , Lot Number 24AMC318
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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