Medline Kits, trays, and packs labeled as follows: a) L&B CDS-LF, REF CDS980273D; b) LABOR AND DELIVERY, REF DYNJ907794; c) LACERATION TRAY, REF DYNDL1864A; d) OBSTETRICAL, REF DYNJ908877; e) UMC EP VAGINAL DELIVERY, REF DYNJ83093;
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-1122-2024
- Quantity
- 2903 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 CDS980273D, UDI/DI 40884389851808 (case), 10884389851807 (unit), Lot Numbers: 22DBJ834; b) REF DYNJ907794, UDI/DI 40193489884952 (case), 10193489884951 (unit), Lot Numbers: 22BBB085, 22CBW699, 22FBH326, 22KBJ007, 22KBW578, 23ABL612, 23CBT573, 23HBD177; c) REF DYNDL1864A, UDI/DI 40889942721420 (case), 10889942721429 (unit), Lot Numbers: 22FBN858, 22IBN393, 23ABJ223, 23EBK530, 23HBS351; d) REF DYNJ908877, UDI/DI 40195327201747 (case), 10195327201746 (unit), Lot Numbers: 22HBT779, 22KBH144, 22LBM695, 23ABD156; e) REF DYNJ83093, UDI/DI 40195327230870 (case), 10195327230869 (unit), Lot Numbers: 22JME508, 23CMH924, 23DMH299, 23EMC295, 23FMB041
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.