NewDeal SA: Medical Device Recall in 2018 - (Recall #: Z-2444-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: May 22, 2018

Date Posted: July 25, 2018

Recall Number: Z-2444-2018

Event ID: 80312

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.

Status: Terminated

Product Quantity:

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

Distribution Pattern:

CA, CO, CT, ID, KS, MA, MD, MN, MO, MS, NC, NY, OH, OR, PA, SD, VA, WA & WI

Voluntary or Mandated:

Voluntary: Firm initiated