Reported Jul 25, 2018 · Terminated
ADVANSYS MLP/DLP, Model Numbers: 181051S, 181052S, 181041S, 181042S, 181031S, 181032S, 181033S, 181021S, 181022S &…
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 MLP/DLP
- Model Numbers
181051S181052S181041S181042S181031S181032S181033S181021S181022S & 181023S
- Lot codes and dates
10 of 10 products
Products covered by this recall # Product as published 1 Lot # FCK9, FG3H & FG3J 181052S 2 Lot # E8PA/G & EB1H/G 181041S 3 Lot # F0AS, F0AT & F0AU 181042S 4 Lot # E8P8/G & EB1F/G 181031S 5 Lot # E8N2/G, E8NL/G, E8P4/G, E8PS/G, EBKW/G, EBKW/G1 & F8EH 181032S 6 Lot # E8P5/G, E8P5/G1, E8PT/G, EB1C/G, EBKX/G & F8EJ 181033S 7 Lot # E8PU/G 181021S 8 Lot # E8NH/G & E8P1/G-EB18/G 181022S 9 Lot # E8MF/G, E8MF/G/Q, E8PQ/G & EBKU/G 181023S 10 Lot # E8MG/G, E8P3/G, E8PR/G & F8EG
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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