—#205655

Product

Medline Kits, trays, and packs labeled as follows: a) C L PREP, REF DYNJ69664; b) DMEK PREP PACK, REF DYNJ81659A; c) PRE OP KIT 1, REF DYKS1377; d) PRE OP KIT 1, REF DYKS1377A

FDA product code: OJU — Skin Prep Tray
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: a) REF DYNJ69664, UDI/DI 40193489966337 (case), 10193489966336 (unit), Lot Numbers: 21LBW095, 22EBT126, 22HBQ767, 22LBB063, 23EBF143; b) REF DYNJ81659A, UDI/DI 40195327277094 (case), 10195327277093 (unit), Lot Numbers: 22KBK040; c) REF DYKS1377, UDI/DI 40195327216673 (case), 10195327216672 (unit), Lot Numbers: 22LLA282; d) REF DYKS1377A , UDI/DI 40195327216673 (case), 10195327216672 (unit), Lot Numbers: 23BLA389

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 #205655. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.