The Recall Desk
HighFDA (Devices)·Z-1088-2023·Announced 2023-02-15

Medline Sterile Surgical Trays Recalled Due to Blade Puncture Risk

Medline Industries recalls sterile surgical procedural trays because sterile blades within the kits may puncture the outer foil packaging, potentially compromising sterility. No injuries or illnesses have been reported.

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: FDA Class II medical device recall involving sterile surgical trays. The hazard—sterile blades potentially puncturing the outer foil packaging—creates risk of compromised sterility and possible post-operative infection in invasive surgical procedures. No illnesses or injuries have been reported, meeting the criterion for High severity as a risk-of-harm product without reported injury.

Plain-English summary

Medline Industries, LP is recalling multiple models of sterile procedural trays used in neurosurgical and other surgical procedures. The affected products include numerous tray variants such as AV SHUNT CDS, ZALE V-P SHUNT CDS, NEURO CDS-LF, and many others.

The recall is due to a potential safety issue: sterile blades within the kits may puncture the outer foil layer of the sterile packaging. If the packaging is compromised, the sterility of the contents cannot be assured.

The affected trays have been distributed worldwide, including throughout the United States and internationally to Canada, Japan, Mexico, Panama, Turks & Caicos, and the United Arab Emirates. The recall affects 6,782 cases containing 15,253 units. No injuries or illnesses related to this issue have been reported.

Healthcare facilities and medical professionals who have received these products should discontinue use immediately and contact Medline Industries for instructions on return or replacement.

The recalled product

Product
Sterile Procedural Trays, labeled as the following: a. AV SHUNT CDS b. ZALE V-P SHUNT CDS c. NEURO CDS-LF d. MAJOR NEURO e. NEURO PACK-LF f. CUSTOM NEURO PACK-LF g. NEURO PACK-LF h. NEURO PACK-LF i. NEURO PACK-LF j. NEURO PACK-LF k. NEURO/LAMINECTOMY BASIN PK-LF l
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Trays / Neurosurgical
Hazard
  • puncture
  • contamination-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 (20)

  • a. AV SHUNT CDS
  • Item Number: CDS983098D
  • Case UDI/GTIN: 40195327191307
  • Unit UDI/GTIN: 10195327191306
  • Lot Number: 22IBD957
  • b. ZALE V-P SHUNT CDS
  • Item Number: CDS983186J
  • Case UDI/GTIN: 40195327105625
  • Unit UDI/GTIN: 10195327105624
  • Lot Number: 22IBT194
  • c. NEURO CDS-LF
  • Item Number: CDS985289
  • Case UDI/GTIN: 40888277050502
  • Unit UDI/GTIN: 10888277050501
  • Lot Number: 22JBH363
  • 22IBF823
  • 22IBD861
  • d. MAJOR NEURO
  • Item Number: CDS985548N
  • Case UDI/GTIN: 40195327033256

Distribution

Distributed nationwide across the United States.

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