inforMED
MalfunctionFYA

STRYKER FLYTE HOOD, PEEL-AWAY

Received Jul 17, 2025

Report MW5172880 · MDR key 22534612

Device

Generic name

Gown, Surgical

Catalog number

0408-800-500

Lot number

0000822522

Product problems

  • Material Fragmentation

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

METAL SHAVING FOUND INSIDE PACKING OF STRYKER FLYTE HOOD, PEEL-AWAY. METAL SHAVING WAS IDENTIFIED PRIOR TO OPENING ONTO THE FIELD. PRODUCT WAS REMOVED FROM OPERATING ROOM. REF: 0408-800-500, LOT:0000822522, EXP: 04/24/2028.