NewDeal SA Recalls ADVANSYS MLP/DLP Medical Devices Due to Infection Risk
NewDeal SA is recalling specific ADVANSYS MLP/DLP models because their use may cause superficial or deep infections requiring medical treatment.
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 care.
Plain-English summary
NewDeal SA is recalling specific models of the ADVANSYS MLP/DLP medical device. The affected model numbers are 181051S, 181052S, 181041S, 181042S, 181031S, 181032S, 181033S, 181021S, 181022S, and 181023S. The recall covers specific lot numbers associated with these models, which are distributed across 19 states including California, New York, and Pennsylvania.
The recall is being issued 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 U.S. Food and Drug Administration has classified this recall as Class II.
Consumers and healthcare providers should check their inventory for the specific model numbers and lot numbers listed in the recall notice. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to the instructions provided by NewDeal SA.
The recalled product
- Product
- ADVANSYS MLP/DLP, Model Numbers: 181051S, 181052S, 181041S, 181042S, 181031S, 181032S, 181033S, 181021S, 181022S & 181023S
- 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 (15)
- 181051S - Lot # FCK9
- FG3H & FG3J 181052S - Lot # E8PA/G & EB1H/G 181041S - Lot # F0AS
- F0AT & F0AU 181042S - Lot # E8P8/G & EB1F/G 181031S - Lot # E8N2/G
- E8NL/G
- E8P4/G
- E8PS/G
- EBKW/G
- EBKW/G1 & F8EH 181032S - Lot # E8P5/G
- E8P5/G1
- E8PT/G
- EB1C/G
- E8MF/G/Q
- E8PQ/G & EBKU/G 181023S - Lot # E8MG/G
- E8P3/G
- E8PR/G & F8EG
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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