The Recall Desk
HighFDA (Devices)·Z-1161-2023·Announced 2023-03-01

Sterile Oncology Port Access Tray Recalled for Sterilization Failure

Medline is recalling sterile oncology port access trays in which some components were not properly sterilized due to improper placement during manufacturing. Healthcare facilities should immediately discontinue use of affected units.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device recall with no reported illnesses or injuries. The hazard is a manufacturing defect resulting in nonsterile components. Per the severity rubric, this is a risk-of-harm product where injury has not been reported, scoring as High (3).

Plain-English summary

Medline Industries, LP is recalling Sterile Oncology Port Access Tray, Item #DYNDC2239. The product is supplied in cases containing 20 sterile kits, each with an Ethicon Biopatch Protective Disk containing chlorhexidine gluconate. Approximately 4,360 trays are affected.

During manufacturing, some components were placed in the nonsterile portion of the tray and did not receive proper sterilization. This could result in components being nonsterile when used.

The affected trays were distributed nationwide to healthcare facilities in Arkansas, Colorado, and Georgia. Multiple lot numbers are involved with expiration dates between 2022 and 2024.

Healthcare providers should immediately stop using affected trays and contact Medline Industries for replacement units. Users can verify lot numbers and expiration dates from their packaging and the official FDA recall notice Z-1161-2023.

The recalled product

Product
Medline Sterile Oncology Port Access Tray, Item #DYNDC2239, 20 sterile kits per case, containing Ethicon Biopatch Protective Disk with CHG, Disk with Chlorhexidine Gluconate (CHG), DRSG Biopatch 1IN NS, VPN: 10150;
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Oncology / Sterile Tray
Hazard
  • sterilization-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 (17)

  • UDI/DI (01) 40888277986412
  • Lot numbers 22OBD978
  • exp. 1/31/2023
  • 22HBR887
  • exp. 12/31/2023
  • 22GBD420
  • 22EBK277
  • 22EBK012
  • exp. 9/30/2023
  • 22EBA934
  • exp. 1/31/2024
  • 22ABK594
  • exp. 4/30/2023
  • 21KBS545
  • exp. 6/30/2022
  • and 21JBL152
  • exp. 2/28/2023.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category