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U.S. Department of Health and Human Services

Class 1 Device Recall Medline procedure kits

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 Class 1 Device Recall Medline procedure kitssee related information
Date Initiated by FirmApril 08, 2024
Date PostedAugust 08, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2442-2024
Recall Event ID 94580
Product Classification Spinal epidural anesthesia kit - Product Code OFT
ProductMedline procedure kits labeled as: 1) CONTINUOUS BLOCK, Pack Number DYNJRA0960C; 2) COMBINED SPINAL AND EPIDURAL, Pack Number DYNJRA1268C; 3) WAL- UNIVERSAL BLOCK TRAY, Pack Number DYNJRA1638C; 4) BASIC DIAGNOSTIC TRAY, Pack Number DYNJRA1928; 5) PREOP NERVE BLOCK TRAY, Pack Number DYNJRA2040; 6) UNIVERSAL BLOCK TRAY, Pack Number DYNJRA2097; 7) PAIN TRAY, Pack Number DYNJRA2230; 8) CONTINUOUS EPIDURAL, Pack Number PAIN1766A; 9) CONTINUOUS/CSE TRAY, Pack Number PAIN1856; 10) CONTINUOUS/CSE TRAY, Pack Number PAIN1856A; 11) 20G SINGLE DOSE EPIDURAL, Pack Number PAIN2047; 12) 20G SINGLE DOSE EPIDURAL/CHLOR, Pack Number PAIN2048
Code Information DYNJRA0960C , Lot Number 23CBH823 ; DYNJRA0960C , Lot Number 23EBC905 ; DYNJRA0960C , Lot Number 23EBV028 ; DYNJRA0960C , Lot Number 23HBO071 ; DYNJRA0960C , Lot Number 24BBI322 ; DYNJRA1268C , Lot Number 22GLB081 ; DYNJRA1268C , Lot Number 22HLA566 ; DYNJRA1268C , Lot Number 22ILA092 ; DYNJRA1268C , Lot Number 22LLA800 ; DYNJRA1268C , Lot Number 23DLA368 ; DYNJRA1268C , Lot Number 23FLA942 ; DYNJRA1268C , Lot Number 23GLA321 ; DYNJRA1268C , Lot Number 23HLA910 ; DYNJRA1268C , Lot Number 23ILA593 ; DYNJRA1638C , Lot Number 23EBA854 ; DYNJRA1638C , Lot Number 23GBE493 ; DYNJRA1638C , Lot Number 23KBJ159 ; DYNJRA1928 , Lot Number 22EBD354 ; DYNJRA1928 , Lot Number 22JBO947 ; DYNJRA1928 , Lot Number 23CBO440 ; DYNJRA1928 , Lot Number 23HBK783 ; DYNJRA1928 , Lot Number 23JBI435 ; DYNJRA1928 , Lot Number 23LBM602 ; DYNJRA1928 , Lot Number 24ABQ693 ; DYNJRA2040 , Lot Number 23CBH893 ; DYNJRA2040 , Lot Number 23HBX547 ; DYNJRA2040 , Lot Number 23JBN538 ; DYNJRA2040 , Lot Number 24ABQ696 ; DYNJRA2040 , Lot Number 24CBG746 ; DYNJRA2097 , Lot Number 23BBO995 ; DYNJRA2230 , Lot Number 23JBU321 ; DYNJRA2230 , Lot Number 23LBC389 ; PAIN1766A , Lot Number 23FLB123 ; PAIN1766A , Lot Number 23GLA313 ; PAIN1766A , Lot Number 24ALA302 ; PAIN1766A , Lot Number 24BLA659 ; PAIN1766A , Lot Number 24BLA888 ; PAIN1766A , Lot Number 24BLA889 ; PAIN1766A , Lot Number 24BLA998 ; PAIN1766A , Lot Number 24CLA003 ; PAIN1766A , Lot Number 24CLA078 ; PAIN1856 , Lot Number 22JLB162 ; PAIN1856 , Lot Number 22LLA409 ; PAIN1856A , Lot Number 23HLB303 ; PAIN1856A , Lot Number 24BLB005 ; PAIN1856A , Lot Number 24BLA682 ; PAIN2047 , Lot Number 24BBH932 ; PAIN2048 , Lot Number 24BBF612
Recalling Firm/
Manufacturer		 MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
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. Link for the posting: https://www.medline.com/media/mkt/pdf/Shenli%20Syringe%20Kitting%20Recall%20info.pdf If you have any questions, please contact the Recall Department at 866-359-1704.
Quantity in Commerce1,679,067 units in total
DistributionWorldwide Distribution: US (nationwide) and OUS countries of: AE, AI, BB, CA, CL, CY, DE, GT, HN, JP, MX, MY, PA, PE, PR, SA, SG, TC, TT, VI, PR, TT, MX, BM, ES, NI, DO, GU, CR, AT, CD, DE, DF, W, and ON.
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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