The Recall Desk
SevereFDA (Devices)·Z-1101-2024·Announced 2024-03-06

Medline Surgical Kits Recalled for Potential Sterility Defects

Medline is recalling surgical kits and trays with components that may lack sterility. The affected products were distributed nationwide and internationally.

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, which establishes a minimum severity of 4 (Severe). The hazard involves potential sterility defects in irrigation solutions used in surgery. While no illnesses have been reported, non-sterile solutions in surgical applications pose a significant risk for patient infection.

Plain-English summary

Medline Industries, LP is recalling multiple surgical kits, trays, and packs that contain specific components manufactured by Nurse Assist. The affected components include 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP, and Saline Flush Syringe. The recall was issued due to the potential lack of sterility in these components, which could result in non-sterile solution being distributed.

The affected kits include products used for various procedures, including thyroid surgery, bronchoscopy, ENT procedures, nasal surgery, and central line cap changes. The recalled products were manufactured with specific lot numbers and have been distributed nationwide throughout the United States, including Puerto Rico, as well as in Canada, the UAE, and Panama.

Consumers and healthcare providers who have received affected products should stop use immediately and contact Medline Industries for return and replacement instructions. The potential for non-sterile irrigation solutions in surgical settings could result in serious infection if used in surgical procedures.

The recalled product

Product
MEDLINE Kits, trays, and packs labeled as follows: a) ASC MINOR THYROID CDS, REF CDS983682F; b) BRONCHOSCOPY KIT, REF DYKE1718A; c) BRONCHOSCOPY KIT, REF DYKE1718B; d) DOUBLE CENTRAL LINE CAP CHANGE, REF DYNDC2214G; e) ENT PACK, REF DYNJ55334C; f) ENT PACK, REF DYNJ4
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Kits and Irrigation Solutions
Hazard

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 CDS983682F
  • UDI/DI 40193489852975 (case)
  • 10193489852974 (unit)
  • lot Numbers: 22DDA235
  • 22GBJ113
  • 23ABQ437
  • 23EBS939
  • b) REF DYKE1718A
  • UDI/DI 40193489494656 (case)
  • 10193489494655 (unit)
  • Lot Numbers: 22FBU098
  • 22HBM601
  • 23ABM389
  • c) REF DYKE1718B
  • UDI/DI 40195327240128 (case)
  • 10195327240127 (unit)
  • Lot Numbers: 23DBE977
  • d) REF DYNDC2214G
  • UDI/DI 40195327051984 (case)
  • 10195327051983 (unit)

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

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Same hazard · non sterile

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