The Recall Desk
HighFDA (Devices)·Z-1034-2023·Announced 2023-02-08

Procedural Trays with Sterile Blades May Have Damaged Packaging

Medline Industries is recalling 45 units of procedural trays containing sterile surgical blades. The sharp blades may puncture the outer sterile packaging, potentially compromising sterility and increasing infection risk.

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 a Class II FDA medical device recall involving surgical instruments where the hazard presents a potential risk of infection from loss of sterility. No injuries or illnesses have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported receive a score of 3 (High).

Plain-English summary

Medline Industries, LP is recalling 45 units of procedural trays labeled as THEDA CLARK TOTAL KNEE CDS that contain sterile surgical blades. The product is intended for use in surgical procedures.

The sterile blades included in these trays have the potential to puncture the outer foil packaging layer that maintains their sterility. If the packaging is breached during handling or storage, the blades may become contaminated or no longer maintain their sterile status, potentially increasing the risk of infection if used in surgical procedures.

The affected product has item number CDSOPP508AG, lot number 22HBO323, and was distributed nationwide to healthcare facilities in Arkansas, Maryland, Washington, and Wisconsin. Affected customers should cease use of these trays and contact Medline Industries for instructions regarding product return or replacement.

The recalled product

Product
Non-sterile procedural trays labeled as THEDA CLARK TOTAL KNEE CDS, 1 per case
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Trays
Hazard
  • sterile-compromise
  • packaging-breach
  • infection-risk

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)

  • Item Number: CDSOPP508AG
  • UDI/GTIN Case: 40195327145140
  • UDI/GTIN Each: 10195327145149
  • Lot Number: 22HBO323

Distribution

Distributed nationwide across the United States.

Related recalls

Same category