Device evidence

device-recall:cfres:210866

(1) Medline Pacer Implant Pack, REF DYNJ59194A, 4 kits/case, sterile; and (2) Medline Thoracotomy Morristown, REF DYNJ904220F, 1 kit/case, non-sterile.

Official recall number

Z-0533-2025

Evidence summary

Product code: LRO
Recall status: Open, Classified
Event initiated: October 15, 2024
Root cause: Mixed-up of materials/components
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-0533-2025