Reported Jul 25, 2018 · Terminated

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

NewDeal SA

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: NewDeal SA · Immeuble Sequoia 2 97 A · St Priest · N/A

Is this the product you have?

  • ADVANSYS TTC
  • Model Numbers
    • 181011S
    • 181012S
    • 181013S
    • 181014S
    • 181001S
    • 181002S
    • 181003S & 181004S
Lot codes and dates

8 of 8 products

Products covered by this recall
#Product as published
1Lot # E8PF/G, F5CE 181012S
2Lot # E8MB/G, E8MV/G & E8PG/G1 181013S
3Lot # E8MC/G, E8MW/G, E8NF/G, E8NF/G1, E8NZ/G, E8PH/G, F538, F5CG & F7G7 181014S
4Lot # E8MD/G, E8NG/G, E8P0/G & E8PJ/1 181001S
5Lot # E8PB/G & F5CA 181002S
6Lot # E8M7/G, E8MR/G & E8PC/G 181003S
7Lot # E8MS/G, E8NB/G, E8NV/G, F537 & F5CC 181004S
8Lot # E8MD/G, E8NG/G, E8P0/G & E8PJ/1

This recall covers 5 products

The agency filed one notice per product. You are reading one of them; the other 4 are below.

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Nov 4, 2019 · Data as of Sep 19, 6:05 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.