Skip to content
Recall Observatory FDA recall evidence

Device product

Centurion Kits, trays, and packs labeled as follows: a) IV SECUREMENT KIT, REF IVS1860B; b) NEONATAL PICC LINE INSERTION TRAY, REF CVI2025; c) NEONATAL PICC LINE INSERTION TRAY, REF CVI4570; d) SECONDARY IV START KIT, REF IV8695A

Z-1134-2024

November 15, 2023

Class I

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 93800
Status
Ongoing
Classification
Class I
Quantity
11812 units
Official record key
device-enforcement:Z-1134-2024

Official wording

Reason: 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.

Code information: a) REF IVS1860B, UDI/DI 00653160351354 (case), 10653160351351 (unit), Lot Numbers: 2022041880, 2022082280; b) REF CVI2025, UDI/DI 50653160060459 (case), 00653160060454 (unit), Lot Numbers: 2022053190; c) REF CVI4570, UDI/DI 00653160323382 (case), 10653160323389 (unit), Lot Numbers: 2022042690, 2022072590, 2022103190, 2023041290, 2023051090; d) REF IV8695A, UDI/DI 00653160348569 (case), 10653160348566 (unit), Lot Numbers: 2021121750, 2022030780

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

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    lack of sterility