The Recall Desk
SevereFDA (Devices)·Z-1122-2024·Announced 2024-03-06

Medline kits and trays recalled for potential lack of sterility

Medline Industries is recalling surgical kits and trays containing irrigation solutions that may not be sterile due to manufacturing issues. The non-sterile solutions could increase infection risk during surgical and obstetrical 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: This is an FDA Class I medical device recall. Under the severity rubric, FDA Class I recalls are scored at minimum 4 (Severe). No illnesses or injuries have been reported, but the potential for infection from non-sterile irrigation solutions used in surgical procedures justifies the FDA's Class I classification.

Plain-English summary

Medline Industries, LP is recalling certain kits, trays, and packs used in obstetrical and surgical procedures. The affected products include labor and delivery kits, laceration trays, obstetrical surgical kits, and vaginal delivery kits with specific reference numbers and lot identifications.

The recalled products contain irrigation solutions that were manufactured using components from Nurse Assist, specifically 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP, and Saline Flush Syringe. Nurse Assist identified a potential lack of sterility in these components, creating a risk that the irrigation solutions supplied in these kits may not be sterile.

The recalled products were distributed nationwide in the United States, as well as to Puerto Rico, Canada, the United Arab Emirates, and Panama.

Healthcare facilities and individuals who have received these products should immediately discontinue use and contact Medline Industries or the FDA for guidance on proper handling, disposal, and replacement of affected units.

The recalled product

Product
Medline Kits, trays, and packs labeled as follows: a) L&B CDS-LF, REF CDS980273D; b) LABOR AND DELIVERY, REF DYNJ907794; c) LACERATION TRAY, REF DYNDL1864A; d) OBSTETRICAL, REF DYNJ908877; e) UMC EP VAGINAL DELIVERY, REF DYNJ83093;
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical / Obstetrical Supplies
Hazard
Affected units
2,903

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 CDS980273D
  • UDI/DI 40884389851808 (case)
  • 10884389851807 (unit)
  • Lot Numbers: 22DBJ834
  • b) REF DYNJ907794
  • UDI/DI 40193489884952 (case)
  • 10193489884951 (unit)
  • Lot Numbers: 22BBB085
  • 22CBW699
  • 22FBH326
  • 22KBJ007
  • 22KBW578
  • 23ABL612
  • 23CBT573
  • 23HBD177
  • c) REF DYNDL1864A
  • UDI/DI 40889942721420 (case)
  • 10889942721429 (unit)
  • Lot Numbers: 22FBN858
  • 22IBN393

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 →

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