The Recall Desk
HighFDA (Devices)·Z-1094-2023·Announced 2023-02-15

Sterile Procedural Trays Recalled Due to Blade Puncture Risk

MEDLINE INDUSTRIES is recalling sterile surgical trays used in robotic and laparoscopic procedures because blades within the kits can puncture the outer foil packaging. The recall affects 1,212 cases (2,101 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: FDA Class II recall with no reported illnesses or injuries. The hazard represents a risk-of-harm scenario where blade puncture could compromise the sterile packaging of surgical instruments, meeting the rubric criterion for High severity.

Plain-English summary

MEDLINE INDUSTRIES, LP is recalling multiple sterile procedural trays used in robotic-assisted and laparoscopic surgeries. The recall affects 1,212 cases containing 2,101 units across various product configurations.

Sterile blades within these surgical kits have the potential to puncture the outer foil layer of the sterile packaging. This could compromise the sterile condition of the surgical instruments.

These products were distributed worldwide, including throughout the United States, Canada, Japan, Mexico, Panama, Turks & Caicos, and the United Arab Emirates.

Affected healthcare facilities should contact MEDLINE INDUSTRIES or review the FDA recall notice for instructions on how to proceed with affected inventory.

The recalled product

Product
Sterile Procedural Trays, labeled as the following: a. CELEBRATION ROBOTIC CDS b. DAVINCI CDS UCC-LF c. ROBOTICS PACK-LF d. ROBOTICS PACK-LF e. ROBOTIC PACK f. PELVISCOPY PACK-LF g. CUSTOM LITHOTOMY ROBOT PACK h. PERI GYN PACK i. ROBOTICS PACK j. LAP HYSTO PACK k.
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Trays
Hazard
  • packaging-puncture
  • sterility-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. CELEBRATION ROBOTIC CDS
  • Item Number: CDS983612C
  • Case UDI/GTIN: 40884389768687
  • Unit UDI/GTIN: 10884389768686
  • Lot Number: 22KBE707
  • 22JBX839
  • 22JBX843
  • b. DAVINCI CDS UCC-LF
  • Item Number: CDS984663G
  • Case UDI/GTIN: 40193489323772
  • Unit UDI/GTIN: 10193489323771
  • Lot Number: 22JBX614
  • c. ROBOTICS PACK-LF
  • Item Number: DYNJ0038258B
  • Case UDI/GTIN: 40889942902089
  • Unit UDI/GTIN: 10889942902088
  • Lot Number: 22IBO524
  • 22HBV626
  • 22HBV627
  • d. ROBOTICS PACK-LF

Distribution

Distributed nationwide across the United States.

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