NewDeal ADVANSYS TTC Medical Devices Recalled for Infection Risk
NewDeal SA is recalling ADVANSYS TTC medical devices because they may cause superficial or deep infections requiring antibiotic treatment or device removal.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of deep infection requiring intravenous antibiotics and device removal, which aligns with the rubric criteria for Severe severity involving significant injury or hospitalization-level medical intervention.
Plain-English summary
NewDeal SA is recalling specific model numbers of the ADVANSYS TTC medical device. The affected models include 181011S, 181012S, 181013S, 181014S, 181001S, 181002S, 181003S, and 181004S. The recall covers specific lot numbers for each model, which are detailed in the agency's official records.
The recall was initiated because the use of the impacted product may cause a superficial infection requiring oral antibiotics and wound care, or a deep infection requiring intravenous antibiotics and device removal. The devices were distributed in California, Colorado, Connecticut, Idaho, Kansas, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, New York, Ohio, Oregon, Pennsylvania, South Dakota, Virginia, Washington, and Wisconsin.
Healthcare providers and patients should stop using the affected devices and contact NewDeal SA for instructions on how to proceed. The U.S. Food and Drug Administration has classified this as a Class II recall.
The recalled product
- Product
- ADVANSYS TTC, Model Numbers: 181011S, 181012S, 181013S, 181014S, 181001S, 181002S, 181003S & 181004S
- Manufacturer
- NewDeal SA
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (17)
- 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
- E8P0/G & E8PJ/1
Distribution
Part of a larger recall action
This product is one of 5 recalled by NewDeal SA under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
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