The Recall Desk
HighFDA (Devices)·Z-1072-2023·Announced 2023-02-15

Medline Sterile Procedural Trays Recalled for Potential Packaging Puncture Risk

Medline Industries is recalling approximately 27,563 units of sterile procedural trays used in surgery because sterile blades may puncture the outer foil packaging layer, potentially compromising sterility.

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 medical device recall. The potential for blade puncture to compromise the sterile packaging barrier represents a risk-of-harm scenario where patient infection could result if contaminated instruments are used in surgery. No illnesses or injuries have been reported, and the hazard is theoretical, meeting the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Medline Industries, LP is recalling 9,079 cases (27,563 units) of sterile procedural trays used in various surgical procedures. The affected products include multiple tray types designed for ear, sinus, head and neck, and other surgical procedures. These trays are distributed worldwide, including throughout the United States, Canada, Japan, Mexico, Panama, Turks & Caicos, and United Arab Emirates.

The recall is due to a potential safety issue: sterile blades within the procedural trays may puncture the outer foil layer of the sterile packaging. If the packaging foil is punctured, the sterile barrier could be compromised, potentially exposing the surgical instruments to contamination before they are used in patient procedures.

No injuries or illnesses related to this issue have been reported to the manufacturer at this time.

Affected product lots and item numbers are detailed in the manufacturer's recall notice. Healthcare facilities should consult the recall notice to verify whether they have received affected products.

The recalled product

Product
Sterile Procedural Trays, labeled as the following: a. EAR CDS-LF b. SINUS CDS-1 c. ZALE FESS CDS d. ZALE OTOLOGY CDS e. ZALE HEAD & NECK CDS f. CUH PARA/THYROIDECTOMY CDS g. CAM ENDOSCOPIC SINUS/SEPTO CDS h. HEAD AND NECK CDS i. HEAD AND NECK CDS-LF j. NASAL k. ENT SET UP CDS l
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Trays / Sterile Procedural Kits
Hazard
  • puncture-hazard
  • loss-of-sterility
  • 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. EAR CDS-LF
  • Item Number: CDS982612B
  • Case UDI/GTIN: 40888277899729
  • Unit UDI/GTIN: 10888277899728
  • Lot Number: 22JBH351
  • 22JBA043
  • b. SINUS CDS-1
  • Item Number: CDS982901F
  • Case UDI/GTIN: 40889942216971
  • Unit UDI/GTIN: 10889942216970
  • Lot Number: 22KBD129
  • c. ZALE FESS CDS
  • Item Number: CDS983178F
  • Case UDI/GTIN: 40195327164639
  • Unit UDI/GTIN: 10195327164638
  • Lot Number: 22JBC334
  • 22IBC429
  • d. ZALE OTOLOGY CDS
  • Item Number: CDS983181F
  • Case UDI/GTIN: 40195327164646

Distribution

Distributed nationwide across the United States.

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