NewDeal UNI-CP Medical Devices Recalled Due to Infection Risk
NewDeal SA is recalling specific UNI-CP medical devices because their use 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 device removal and IV antibiotics, which aligns with the rubric criterion for 'Severe' (FDA Class II with significant injury/property-damage reports or high-risk medical consequences).
Plain-English summary
NewDeal SA is recalling specific models of the UNI-CP medical device, including model numbers 330021S through 330430S. The recall covers specific lot numbers distributed across 19 states, including California, Colorado, Connecticut, Idaho, Kansas, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, New York, Ohio, Oregon, Pennsylvania, South Dakota, Virginia, Washington, and Wisconsin.
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 source text does not report any specific number of illnesses, injuries, or deaths associated with this recall.
Consumers who have these specific UNI-CP devices should stop using them and contact NewDeal SA for instructions on how to return or dispose of the product. The recall is classified as Class II by the FDA, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- UNI-CP, Model Numbers: 330021S, 330023S, 330025S, 330030S, 330025S, 30030S, 330217S, 330220S, 330225S, 330230S, 330420S, 330425S, & 330430S
- 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 (20)
- 330021S - Lot # F8ML
- FEDJ & FF38 330023S - Lot # EF05/G
- EGNK/G
- F8MM
- F9J2
- FAPZ
- FBE8
- FBPB
- FCFQ
- FCJP
- FEDK
- FF39 & FFH7 330025S - Lot # FAE6
- FBPC
- FCFR
- FCJQ
- FEDL & FFH8 330030S - Lot # EMGF/1
- ENHN
- EPQM-FBE5
- FBPD
- FBPE
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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