Z-2445-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 25, 2018
- Initiation Date
- May 22, 2018
- Termination Date
- November 4, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
ADVANSYS MLP/DLP, Model Numbers: 181051S, 181052S, 181041S, 181042S, 181031S, 181032S, 181033S, 181021S, 181022S & 181023S
Reason for Recall
Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device removal.
Distribution Pattern
CA, CO, CT, ID, KS, MA, MD, MN, MO, MS, NC, NY, OH, OR, PA, SD, VA, WA & WI
Code Information
181051S - Lot # FCK9, FG3H & FG3J 181052S - Lot # E8PA/G & EB1H/G 181041S - Lot # F0AS, F0AT & F0AU 181042S - Lot # E8P8/G & EB1F/G 181031S - Lot # E8N2/G, E8NL/G, E8P4/G, E8PS/G, EBKW/G, EBKW/G1 & F8EH 181032S - Lot # E8P5/G, E8P5/G1, E8PT/G, EB1C/G, EBKX/G & F8EJ 181033S - Lot # E8PU/G 181021S - Lot # E8NH/G & E8P1/G-EB18/G 181022S - Lot # E8MF/G, E8MF/G/Q, E8PQ/G & EBKU/G 181023S - Lot # E8MG/G, E8P3/G, E8PR/G & F8EG