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U.S. Department of Health and Human Services

Class 2 Device Recall Medline Convenience kits

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 Class 2 Device Recall Medline Convenience kitssee related information
Date Initiated by FirmMarch 03, 2025
Date PostedApril 17, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1594-2025
Recall Event ID 96510
Product Classification CT biopsy tray - Product Code OFG
ProductMedline Convenience kits used for various procedures: 1) LARGE BIOPSY PACK NTX, Model Number: DYNJ68393A; 2) SOFT TISSUE BIOPSY PACK, Model Number: DYNJ81441B; 3) BILAT TESTICULAR SPERM EXTRACT, Model Number: DYNJ68303; 4) PROCEDURE MINEURE BJC-LF, Model Number: DYNJ41678B; 5) PROCEDURE MINEURE BJC-LF, Model Number: DYNJ41678B; 6) PHLEBECTOMY PACK, Model Number: DYNJ55215G; 7) BIOPSY/DRAINAGE TRAY-LF, Model Number: DYNJ30078D; 8) CAT BIOPSY PACK, Model Number: DYNJ62968; 9) ABLATION/DRAINAGE PACK, Model Number: DYNJ53658D; 10) BIOPSY KIT, Model Number: DYNJ61130B
Code Information 1) DYNJ68393A, UDI-DI: 10193489939996(each), 40193489939997(case), Lot Number: 24IBP745; 2) DYNJ81441B, UDI-DI: 10198459111105(each), 40198459111106(case), Lot Number: 24JBB770; 3) DYNJ68303, UDI-DI: 10193489821529(each), 40193489821520(case), Lot Number: 24JBU406; 4) DYNJ41678B, UDI-DI: 10198459124129(each), 40198459124120(case), Lot Number: 24JBW438; 5) DYNJ41678B, UDI-DI: 10198459124129(each), 40198459124120(case), Lot Number: 24JBW452; 6) DYNJ55215G, UDI-DI: 10193489925555(each), 40193489925556(case), Lot Number: 24KBC666; 7) DYNJ30078D, UDI-DI: 10889942138647(each), 40889942138648(case), Lot Number: 24KBD430; 8) DYNJ62968, UDI-DI: 10193489706239(each), 40193489706230(case), Lot Number: 24KBE699; 9) DYNJ53658D, UDI-DI: 10195327672140(each), 40195327672141(case), Lot Number: 24KBF023; 10) DYNJ61130B, UDI-DI: 10195327054588(each), 40195327054589(case), Lot Number: 24KBG714
Recalling Firm/
Manufacturer		 MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information ContactHaley Barclay
866-359-1704
Manufacturer Reason
for Recall		There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
FDA Determined
Cause 2		Under Investigation by firm
ActionAn IMMEDIATE ACTION REQUIRED MEDLINE DEVICE RECALL notification letter dated 3/3/25 was sent to customers. REQUIRED ACTION: 1.Immediately check your stock for the affected item number and the affected lot numbers which can be located within the recall portal. 2.Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response form. 3.Please destroy any affected inventory. Medline will issue credit for the product based upon the quantity and lot numbers identified on the submitted response form The login for completing the response form is: Website link: https://recalls.medline.com Recall Reference #: R-25-050-FG Recall Code: RECALL CODE 4.If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please request that customers document and destroy any affected product, and include your customer s quantities on your response form. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
Quantity in Commerce1126 units
DistributionWorldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.
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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