RecallRadar

FDA Device recall Z-1134-2024

Centurion Kits, trays, and packs labeled as follows: a) IV SECUREMENT KIT, REF IVS1860B

On 2024-03-06 the FDA classified a Class I recall of Centurion Kits, trays, and packs labeled as follows: a) IV SECUREMENT KIT, REF IVS1860B by Medline Industries Northfield, citing 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….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1134-2024
ClassificationClass I
Statusongoing
Initiated2023-11-15
Published2024-03-06
Last updated2026-09-13 11:57 UTC
CompanyMedline Industries Northfield
DistributionUS

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

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.

Identifiers

code_info
a) REF IVS1860B, UDI/DI 00653160351354 (case), 10653160351351 (unit), Lot Numbers: 2022041880, 2022082280; b) REF CV…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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1134-2024%22

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