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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-2443-2024
Recall Event ID 94580
Product Classification Nerve block tray - Product Code OGJ
ProductMedline procedure kits labeled as: 1) NEPHROLOGY PACK, Pack Number DYNJ59089; 2) NERVE BLOCK TRAY, Pack Number DYNJRA1221A
Code Information DYNJ59089 , Lot Number 23IBF074 ; DYNJRA1221A , Lot Number 20IDB255 ; DYNJRA1221A , Lot Number 22BDA978 ; DYNJRA1221A , Lot Number 22KDA950 ; DYNJRA1221A , Lot Number 22LDA146 ; DYNJRA1221A , Lot Number 23ADB422 ; DYNJRA1221A , Lot Number 23BDB453 ; DYNJRA1221A , Lot Number 23IDA424 ; DYNJRA1221A , Lot Number 23JDB010
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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