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
181011S181012S181013S181014S181001S181002S181003S & 181004S
- Lot codes and dates
8 of 8 products
Products covered by this recall # Product as published 1 Lot # E8PF/G, F5CE 181012S 2 Lot # E8MB/G, E8MV/G & E8PG/G1 181013S 3 Lot # E8MC/G, E8MW/G, E8NF/G, E8NF/G1, E8NZ/G, E8PH/G, F538, F5CG & F7G7 181014S 4 Lot # E8MD/G, E8NG/G, E8P0/G & E8PJ/1 181001S 5 Lot # E8PB/G & F5CA 181002S 6 Lot # E8M7/G, E8MR/G & E8PC/G 181003S 7 Lot # E8MS/G, E8NB/G, E8NV/G, F537 & F5CC 181004S 8 Lot # 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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