The Recall Desk
SevereFDA (Devices)·Z-1129-2024·Announced 2024-03-06

Medical maintenance flush kits recalled for potential sterility defect

Medline Industries is recalling Centurion maintenance flush and blood draw kits due to potential sterility issues in component solutions. Affected lot numbers are 2022031480 and 2022041180.

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: This is an FDA Class I recall. Per the rubric, FDA Class I recalls never score below 4 (Severe). Although no illnesses or injuries are reported in the source text, the potential for non-sterile solutions in medical kits used for injection and blood draw represents serious risk of infection.

Plain-English summary

Medline Industries, LP is recalling certain Centurion maintenance flush and blood draw kits (REF DT19335A) manufactured with specific lots of components from Nurse Assist. A total of 220 units were distributed nationwide across the United States, Puerto Rico, Canada, United Arab Emirates, and Panama.

The recalled kits contain components including 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP, and Saline Flush Syringe. The recall was initiated because these components may have a potential lack of sterility, which could result in non-sterile solutions.

Affected lot numbers are 2022031480 and 2022041180. The FDA has classified this as a Class I recall, indicating the most serious type of medical device recall.

Healthcare facilities and professionals should identify products using these lot numbers in their inventory and ensure they are not used for patient care. The recalling firm is Medline Industries, LP.

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
  • lack-of-sterility
  • contamination

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 (4)

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

Distribution

Distributed nationwide across the United States.