The Recall Desk
HighFDA (Devices)·Z-1065-2023·Announced 2023-02-15

Blade Puncture Risk in Femoral Artery Sterile Procedural Trays

Medline's Femoral Artery Sterile Procedural Trays are being recalled because sterile blades within the kits can puncture the outer foil layer of the sterile packaging. This puncture creates a contamination 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 an FDA Class II recall with no reported hospitalizations or confirmed injuries. The hazard presents a risk of harm (sterile packaging breach potentially leading to contamination), but injury has not yet been reported. Per the rubric, this qualifies as 'High' severity.

Plain-English summary

Medline Industries is recalling 30 units of its Femoral Artery Sterile Procedural Tray (Item Number DYNJ0826625Q) with lot numbers 22KMA163 and 22JME722. The recall is due to a potential safety hazard: the sterile blades contained within the procedural kits can puncture the outer foil layer of the sterile packaging during handling or use.

If the sterile foil packaging is punctured, the contents may no longer be maintained in a sterile condition. This creates a risk of contamination that could compromise the safety and effectiveness of the procedural tray during medical procedures. The affected units have been distributed worldwide, including throughout the United States, Canada, Japan, Mexico, Panama, the Turks and Caicos Islands, and the United Arab Emirates.

Facilities and healthcare providers who received these procedural trays should immediately discontinue use and contact Medline Industries for replacement units or return instructions. Do not use any tray with lot numbers 22KMA163 or 22JME722. If any of these units have already been used in a procedure, contact the manufacturer immediately.

The recalled product

Product
FEMORAL ARTERY PACK-LF. Sterile Procedural Tray
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Procedural Tray
Hazard
  • puncture
  • sterile-packaging-breach
  • 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 (5)

  • Item Number: DYNJ0826625Q
  • Case UDI/GTIN: 40193489377942
  • Unit UDI/GTIN: 10193489377941
  • Lot Number: 22KMA163
  • 22JME722

Distribution

Distributed nationwide across the United States.

Related recalls

Same category