Home / Recalls / NewDeal SA / Z-2444-2018

Z-2444-2018 Class II Terminated

Recalled by NewDeal SA — St Priest

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 TTC, Model Numbers: 181011S, 181012S, 181013S, 181014S, 181001S, 181002S, 181003S & 181004S

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

181011S - Lot # E8PF/G, F5CE 181012S - Lot # E8MB/G, E8MV/G & E8PG/G1 181013S - Lot # E8MC/G, E8MW/G, E8NF/G, E8NF/G1, E8NZ/G, E8PH/G, F538, F5CG & F7G7 181014S - Lot # E8MD/G, E8NG/G, E8P0/G & E8PJ/1 181001S - Lot # E8PB/G & F5CA 181002S - Lot # E8M7/G, E8MR/G & E8PC/G 181003S - Lot # E8MS/G, E8NB/G, E8NV/G, F537 & F5CC 181004S - Lot # E8MD/G, E8NG/G, E8P0/G & E8PJ/1

Other recalls by NewDeal SA

  • Z-2446-2018 Class II — Large QWIX, Model Numbers: 111740S, 111745S, 111750S, 111755S, 111760S, 111765 (May 22, 2018)
  • Z-2443-2018 Class II — UNI-CP, Model Numbers: 330021S, 330023S, 330025S, 330030S, 330025S, 30030S, 3302 (May 22, 2018)
  • Z-2447-2018 Class II — TIBIAXYS, Model Numbers: 150010S, 150020S, 150030S, 150040S, 150120S, 150110S, (May 22, 2018)
  • Z-2445-2018 Class II — ADVANSYS MLP/DLP, Model Numbers: 181051S, 181052S, 181041S, 181042S, 181031S, 18 (May 22, 2018)