—#205654

Product

Medline Kits, trays, and packs labeled as follows: a) BLOOD DRAW KIT, REF DYNDV2183A; b) LCPH LAB DRAW KIT, REF DYNDH1641A; c) LCPH LAB DRAW KIT, REF DYNDH1641AH; d) OB LAB COLLECTION KIT, REF DYNDH1719A;

FDA product code: OIB — Blood And Urine Collection Kit (Excludes Hiv Testing)
Device class: Class 1
Medical specialty: Pathology
Affected lot / code info: a) REF DYNDV2183A, UDI/DI 40195327050710 (case), 10195327050719 (unit), Lot Numbers: 22ABT635, 22ABY152, 22BBO850; b) REF DYNDH1641A, UDI/DI 40195327003273 (case), 10195327006839 (unit), Lot Numbers: 22DMB468; c) REF DYNDH1641AH, UDI/DI 40195327003273 (case), 10195327006839 (unit), Lot Numbers: 22DMB468; d) REF DYNDH1719A, UDI/DI40889942880486 (case), 10889942880485 (unit), Lot Numbers: 23ABC589, 23ABR972, 23BBS014

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 #205654. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.