—#205633

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 KIT, REF DYKE1364B; e) ENDO KIT, REF DYKE1892; f) ENDO KIT W/ BLUE TOTE BAG, REF DYKE1648I; g) EYE KIT, REF DYKM2222; h) LAP CHOLE CDS, REF CDS983912Y; i) PLASTICS SUTURE TRAY, REF SUT13535; j) SNES ENDO KIT, REF DYKE1930A

FDA product code: NWU — Endoscope Introducer Kit
Device class: Class 2
Medical specialty: Gastroenterology, Urology
Affected lot / code info: 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

Why it was 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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

MEDLINE 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.

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama

Timeline

Recall initiated: 2023-11-15
Posted by FDA: 2024-02-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #205633. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.