FDAClass IIJuly 25, 2018

UNI-CP recall

UNI-CP, Model Numbers: 330021S, 330023S, 330025S, 330030S, 330025S, 30030S, 330217S, 330220S, 330225S, 330230S, 330420S, 330425S, & 330430S

Why was UNI-CP 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
UNI-CP, Model Numbers: 330021S, 330023S, 330025S, 330030S, 330025S, 30030S, 330217S, 330220S, 330225S, 330230S, 330420S, 330425S, & 330430S
Recalling firm
NewDeal SA
Distribution
CA, CO, CT, ID, KS, MA, MD, MN, MO, MS, NC, NY, OH, OR, PA, SD, VA, WA & WI
Recall date
July 25, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls