Medline Kits recall: Sterility Concern
MEDLINE Kits, trays, and packs labeled as follows: a) C-SECTION, REF DYNJ904653G; b) DRESSING TRAY, REF M101426; c) ENDO KIT, REF DYKE1387; d) ENDO…
Why was Medline Kits recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
a) REF DYNJ904653G, UDI/DI 40195327279951 (case), 10195327279950 (unit), Lot Numbers: 23ABE326; b) REF M101426, UDI/DI 40195327279951 (case), 10195327279950 (unit), Lot Numbers: 23ABD269; c) REF DYKE1387, UDI/DI 40889942384007 (case), 10889942384006 (unit), Lot Numbers: 22FBC677, 22FBU123, 22HBA432, 22JBG195, 23ABF156, 23BBE110, 23CBG139, 23CBU443; d) REF DYKE1364B, UDI/DI 40195327162734 (case), 10195327162733 (unit), Lot Numbers: 22FBV837, 22HBL534, 22IMH103, 22KMA408, 22LMG525; e) REF DYKE1892, UDI/DI 40195327279951 (case), 10195327279950 (unit), Lot Numbers: 23ABD211, 23CBX144, 23FBN050; f) REF DYKE1648I, UDI/DI 40195327279951 (case), 10195327279950 (unit), Lot Numbers: 23CBX187; g) REF DYKM2222, UDI/DI 40195327279951 (case), 10195327279950 (unit), Lot Numbers: 23FBO502; h) REF CDS983912Y, UDI/DI 40195327279951 (case), 10195327279950 (unit), Lot Numbers: 23FBO144 i) REF SUT13535, UDI/DI 40195327279951 (case), 10195327279950 (unit), Lot Numbers: 23CBX181; j) REF DYKE1930A, UDI/DI 40195327449224 (case), 10195327449223 (unit), Lot Numbers: 23FBR603, 23HBO128
- Product
- MEDLINE Kits, trays, and packs labeled as follows: a) C-SECTION, REF DYNJ904653G; b) DRESSING TRAY, REF M101426; c) ENDO KIT, REF DYKE1387; d) ENDO…
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 5969 units
- Distribution
- Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama
- Recall date
- March 6, 2024
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)