The Recall Desk
HighFDA (Devices)·Z-1096-2023·Announced 2023-02-15

Medline Sterile Procedural Trays Recalled Due to Packaging Puncture Risk

Medline recalls sterile procedural trays because blades may puncture the foil packaging, potentially compromising sterility. The recall affects over 227,000 units distributed worldwide.

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 recall involving sterile medical devices used in surgical procedures. The potential for blade puncture to compromise packaging and compromise sterility presents a risk of infection. No illnesses have been reported in the source material, fitting the rubric criterion of risk-of-harm products without reported injury.

Plain-English summary

Medline Industries is recalling 101,102 cases (227,538 units) of sterile procedural trays due to a packaging integrity issue. The recalled products include numerous different tray configurations used in orthopedic, spine, cardiac, and other surgical procedures.

The reason for the recall is that sterile blades within these kits have the potential to puncture the outer foil layer of the sterile packaging. A breach in this packaging could compromise the sterility of the surgical instruments and increase the risk of infection during procedures.

These trays were distributed worldwide, including throughout the United States, Canada, Japan, Mexico, Panama, Turks and Caicos, and the United Arab Emirates. The distribution includes hospitals, surgery centers, and other healthcare facilities.

Healthcare providers and consumers with affected products should contact Medline Industries for information about this recall.

The recalled product

Product
Sterile Procedural Trays, labeled as the following: a. SPINAL b. SPINE CDS c. TOTAL ORTHO CDS d. TOTAL KNEE CDS e. CDS HIP-LF f. KNEE TOTAL PACK-LF g. EXTREMITY CDS h. SHOULDER ARTHRO CDS i. GLENNON EXTREMITY CDS j. KNEE ARTHROSCOPY k. TOTAL KNEE l. TOTAL HIP REPLACEMENT m. TO
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical/Procedural Trays
Hazard
  • blade-puncture
  • packaging-defect
  • sterility-compromise

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. SPINAL
  • Item Number: CDS780198O
  • Case UDI/GTIN: 40193489754101
  • Unit UDI/GTIN: 10193489754100
  • Lot Number: 22JBP283
  • b. SPINE CDS
  • Item Number: CDS780228D
  • Case UDI/GTIN: 40193489538329
  • Unit UDI/GTIN: 10193489538328
  • Lot Number: 22JMG559
  • c. TOTAL ORTHO CDS
  • Item Number: CDS940243K
  • Case UDI/GTIN: 40193489883443
  • Unit UDI/GTIN: 10193489883442
  • Lot Number: 22JBY480
  • d. TOTAL KNEE CDS
  • Item Number: CDS941144V
  • Case UDI/GTIN: 40195327132393
  • Unit UDI/GTIN: 10195327132392
  • Lot Number: 22JMG178

Distribution

Distributed nationwide across the United States.

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