The Recall Desk
SevereFDA (Devices)·Z-1099-2024·Announced 2024-03-06

Medline Centurion maintenance flush kits recalled for sterility failure

Medline Industries is recalling Centurion maintenance flush and blood draw kits that may lack sterility due to defective components, potentially allowing infections during medical procedures.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I classification mandates a minimum severity score of 4. The recall involves potential loss of sterility in medical irrigation solutions used in clinical procedures, creating infection risk. No illnesses or deaths are reported in the source text.

Plain-English summary

Medline Industries, LP is recalling certain Centurion maintenance flush kits and blood draw kits (model DT19335A). The kits were manufactured using components from Nurse Assist that include 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP, and Saline Flush Syringe.

The components were subject to a recall by Nurse Assist due to a potential lack of sterility. If the irrigation solutions are non-sterile, they could pose a risk of infection when used in medical procedures.

The affected kits were distributed nationwide throughout the United States, including Puerto Rico, Canada, the United Arab Emirates, and Panama. Specific lot numbers are 2022031480 and 2022041180. The kits are identified by UDI/DI 00653160348477 (case level) and 10653160348474 (unit level).

Healthcare providers that have received these kits should discontinue use and contact Medline Industries regarding return or replacement.

The recalled product

Product
Centurion Kits, trays, and packs labeled as follows: MAINTENANCE FLUSH KIT/BLOOD DRAW, REF DT19335A
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Hazard
  • non-sterile
  • infection-risk
  • sterility-failure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • UDI/DI 00653160348477 (case)
  • 10653160348474 (unit)
  • Lot Numbers: 2022031480 2022041180

Distribution

Distributed nationwide across the United States.