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U.S. Department of Health and Human Services

Class 1 Device Recall MEDLINE

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 Class 1 Device Recall MEDLINEsee related information
Date Initiated by FirmNovember 15, 2023
Date PostedFebruary 25, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1098-2024
Recall Event ID 93800
Product Classification CT biopsy tray - Product Code OFG
ProductMEDLINE Kits, trays, and packs labeled as follows: a) Description, REF DYNDH1679; b) BREAST BIOPSY TRAY, REF DYNDH1664; c) BREAST BIOPSY TRAY, REF DYNDH1431A; d) BREAST BIOPSY TRAY, REF DYNJ46448; e) BREAST BIOPSY TRAY, REF DYKE1520B; f) COLON KIT- BERLIN, REF DYNDH1808;
Code Information a) REF DYNDH1679, UDI/DI 40653160991534 (case), 10195327007041 (unit), Lot Numbers: DYNDH1431A; b) REF DYNDH1664, UDI/DI 40193489993930 (case), 10193489993929 (unit), Lot Numbers: DYNDH1664; c) REF DYNDH1431A, UDI/DI 40889942880486 (case), 10889942880485 (unit), Lot Numbers: DYNDH1679; d) REF DYNJ46448, UDI/DI 40888277261465 (case), 10888277261464 (unit), Lot Numbers: 23ADA841; e) REF DYKE1520B, UDI/DI 40193489374958 (case), 10193489374957 (unit), Lot Numbers: 22ABB336, 22EBF090, 22FBF262, 22GBI072, 22HBE089, 22JBW122, 22OBH222, 23ABI623, 23BBL273, 23DBF391, 23FBJ442; f) REF DYNDH1808, UDI/DI 40195327264308 (case), 10195327264307 (unit), Lot Numbers: DYNDH1808, DYNDH1808, DYNDH1808
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		Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionMEDLINE issued an IMMEDIATE ACTION REQUIRED NURSE ASSIST PRODUCT RECALL notice to its consignees on 11/16/2023 via USPS first class mail and email. The notice explained the problem, requested log on to their portal to identify the products and check their inventory so the product could be quarantined. Once Medline receives the completed response form, over-labels will be shipped to the consignee. Medline Industries, LP instructed customers to over-label the convenience kits with a warning label indicating to remove the sodium chloride irrigation or Sterile water and replace from a different sterile supply. Distributors or consignees who further distributed the affected products were directed to notify their customers. For questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
DistributionDistribution US nationwide including Puerto Rico, Canada, UAE, and Panama
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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