MEDLINE Kits, trays, and packs labeled as follows: a) ENDO KIT, REF DYKE1350D; b) PANENDOSCOPY-LF, REF DYNJ36728C; c) UMBILICAL VESSEL INSERTION, REF UVT1170; d) UMBILICAL VESSEL INSERTION, REF UVT1170H
This recall is currently active, issued February 25, 2024. It was issued by Medline Industries, Lp - Northfield.
- Recall Initiated
- November 15, 2023
- Posted
- February 25, 2024
- Recall Number
- Z-1106-2024
- Quantity
- 1184 units
- Firm Location
- Northfield, IL
- Official Source
- View on FDA website ↗
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.
Distribution
Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama
Lot / Code Info
a) REF DYKE1350D; UDI/DI 40193489339797 (case), 10193489339796 (unit), Lot Numbers: 22FBT089, 22LBN853, 23CBI535, 23DBQ149, 23EBI601; b) REF DYNJ36728C; UDI/DI 40193489265911 (case), 10193489265910 (unit), Lot Numbers: 22BBJ543, 22FBD924, 22HBR956, 23BBF230, 23FBG752; c) REF UVT1170; UDI/DI 40653160991244 (case), 10653160991243 (unit), Lot Numbers: 21LBK307, 22DMH696; d) REF UVT1170H; UDI/DI 40653160991244 (case), 10653160991243 (unit), Lot Numbers: 21LBK307, 22DMH696
Root Cause
Nonconforming Material/Component
Action Taken
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.