Device product
ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite System and USA Series Right Angle Cutting Loop Electrode Stabilized, 0.012 Wire 24 Fr (8mm), Model: REF MLE 24-012. Product packaged in boxes of 6 pouches. Box of 6 has correct box label of ACMI USA Elite System and USA Series Roller Bar Electrode 24/26 Fr (8/8.667 mm), Model: REF RB,
Z-0568-2024
Product summary
- Event
- Event 93417
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 162 pieces (27 boxes, 6 per box)
- Official record key
device-enforcement:Z-0568-2024
Official wording
Reason: Incorrect pouch labels, the contents within the mislabeled pouch were Roller Bar electrodes.
Code information: UDI-DI: 00821925036413 (Incorrect Right Angle Cutting Loop pouch label) UDI-DI: 00821925036444 (Correct on Roller Bar Electrode box label) Lot: KR260855
Distribution pattern: US: AL, FL, GA, KS, LA, MD, MI, NC, NJ, NY, TX, WI & WV and Canada.
Derived failure modes
-
Labeling or packaging
mislabeled