The Recall Desk
SevereFDA (Devices)·Z-1117-2024·Announced 2024-03-06

Medline Surgical Kits Recalled for Potential Lack of Sterility

Medline Industries recalls multiple surgical and central line kits containing Nurse Assist components that may lack sterility. Approximately 86,699 units of these medical device kits have been distributed nationwide.

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, establishing a minimum severity of 4 per the rubric. No deaths, injuries, or illnesses are reported in the source text, so the classification is Severe rather than Critical. The hazard is potential lack of sterility in medical device components.

Plain-English summary

Medline Industries, LP is recalling multiple surgical and central line kits and trays manufactured with specific lot numbers of Nurse Assist components. The recalled components include 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP, and Saline Flush Syringe. The recall was issued due to potential lack of sterility in these components.

According to the recall notice, the solutions may be non-sterile. These kits are medical devices designed to provide sterile solutions for surgical and central line procedures. This is a Class I FDA recall.

Approximately 86,699 units of these medical device kits have been distributed nationwide in the United States, Puerto Rico, Canada, United Arab Emirates, and Panama. Specific product reference numbers and affected lot numbers are detailed in the FDA recall notice.

Healthcare providers should identify potentially affected products using the FDA recall notice and follow Medline Industries' guidance regarding return or quarantine of recalled items.

The recalled product

Product
Medline Kits, trays, and packs labeled as follows: a) CENTRAL LINE TRAY, REF CVI4705; b) DAILY DRIVELINE MGMT KIT w/PER, REF DT18700; c) DRESSING CHANGE TRAY, REF DYNDC3131A; d) DRIVELINE MAINTENANCE PACKAGE, REF DT17405A; e) DRSG CHANGE TRAY W/ CHG, REF DT21460B; f)
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical and Central Line Kits
Hazard
Affected units
86,699

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 (20)

  • a) REF CVI4705
  • UDI/DI 40195327056125 (case)
  • 10195327056124 (unit)
  • Lot Numbers: 23FMD562
  • b) REF DT18700
  • UDI/DI 653160275087 (case)
  • 10653160275084 (unit)
  • Lot Numbers
  • 23BBJ923
  • 23CBB549
  • 23FBM548
  • 23GBF094
  • 23GBR827
  • 23HBM237
  • c) REF DYNDC3131A
  • UDI/DI 40195327105694 (case)
  • 10195327105693 (unit)
  • Lot Numbers: 22CBJ619
  • 22DBD254
  • 22IBG214

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 49 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 49 products in this recall →

Related recalls

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

See all →

Same hazard · sterility failure

See all →