FDA Device recall Z-2443-2018
UNI-CP, Model Numbers: 330021S, 330023S, 330025S, 330030S, 330025S, 30030S, 330217S, 330220S, 330225S, 330230S, 330420S, 330425S, & 330430S
- FDA Device
- Class II
- terminated
- Published 2018-07-25
On 2018-07-25 the FDA classified a Class II recall of UNI-CP, Model Numbers: 330021S, 330023S, 330025S, 330030S, 330025S, 30030S, 330217S, 330220S, 330225S, 330230S, 330420S, 330425S, & 330430S by Newdeal, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2443-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-05-22 |
| Published | 2018-07-25 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Newdeal |
| Distribution | CA, CO, CT, ID, KS, MA, MD, MN, MO, MS, NC, NY, OH, OR, PA, SD, VA, WA, WI |
Product
UNI-CP, Model Numbers: 330021S, 330023S, 330025S, 330030S, 330025S, 30030S, 330217S, 330220S, 330225S, 330230S, 330420S, 330425S, & 330430S
Reason
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.
Identifiers
| code_info | 330021S - Lot # F8ML, FEDJ & FF38 330023S - Lot # EF05/G, EGNK/G, F8MM, F9J2, FAPZ, FBE8, FBPB, FCFQ, FCJP, FEDK, FF3…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, FBPF, FEDM, FEXQ, FEXR, FFH9 & FGHY 330217S - Lot # F7BY, F7BZ, F7C0-F7C1, F7MV, F98K, F9K7, FAFY, FAQ0, FC2Y, FCJR, FEDN, FEDP, FFHA, FFHB 330220S - Lot # F7C2, F7C3, F7C3/1, F7MW, F8KW, F8WR, F9J1, FAQ1, FBP3, FC2Z, FD69, FEDQ, FEDR, FGNC & FHLM 330225S - Lot # F7N0, F8P5, F8WS-, FAQ2, FBP4, FEDS & FHLN 330230S - Lot # F7MX, F8WT, F9SZ, FAFZ, FBE6, FEDT, FEDT/1 & FEDT/Q 330420S - Lot # F7C4, F7MY, F8WU, F942, F9CK, FA80, FB9L, FBPG, FEDU & FGJD 330425S - Lot # F7MZ, F8P6, F8XQ, F9K8, FB4X, FBPH, FBPJ, FF3A & FFHD 330430S - Lot # F7C5, F9EU, F9SY, FA81, FB9M, FBE7, FBPK, FEDV & FFHE |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2443-2018%22
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