Reported Jul 25, 2018 · Terminated
UNI-CP, Model Numbers: 330021S, 330023S, 330025S, 330030S, 330025S, 30030S, 330217S, 330220S, 330225S, 330230S,…
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?
- UNI-CP
- Model Numbers
330021S330023S330025S330030S330025S30030S330217S330220S330225S330230S330420S330425S& 330430S
- Lot codes and dates
11 of 11 products
Products covered by this recall # Product as published 1 Lot # F8ML, FEDJ & FF38 330023S 2 Lot # EF05/G, EGNK/G, F8MM, F9J2, FAPZ, FBE8, FBPB, FCFQ, FCJP, FEDK, FF39 & FFH7 330025S 3 Lot # FAE6, FBPC, FCFR, FCJQ, FEDL & FFH8 330030S 4 Lot # EMGF/1, ENHN, EPQM-FBE5, FBPD, FBPE, FBPF, FEDM, FEXQ, FEXR, FFH9 & FGHY 330217S 5 Lot # F7BY, F7BZ, F7C0-F7C1, F7MV, F98K, F9K7, FAFY, FAQ0, FC2Y, FCJR, FEDN, FEDP, FFHA, FFHB 330220S 6 Lot # F7C2, F7C3, F7C3/1, F7MW, F8KW, F8WR, F9J1, FAQ1, FBP3, FC2Z, FD69, FEDQ, FEDR, FGNC & FHLM 330225S 7 Lot # F7N0, F8P5, F8WS-, FAQ2, FBP4, FEDS & FHLN 330230S 8 Lot # F7MX, F8WT, F9SZ, FAFZ, FBE6, FEDT, FEDT/1 & FEDT/Q 330420S 9 Lot # F7C4, F7MY, F8WU, F942, F9CK, FA80, FB9L, FBPG, FEDU & FGJD 330425S 10 Lot # F7MZ, F8P6, F8XQ, F9K8, FB4X, FBPH, FBPJ, FF3A & FFHD 330430S 11 Lot # F7C5, F9EU, F9SY, FA81, FB9M, FBE7, FBPK, FEDV & FFHE
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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