Z-2443-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 25, 2018
- Initiation Date
- May 22, 2018
- Termination Date
- November 4, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
UNI-CP, Model Numbers: 330021S, 330023S, 330025S, 330030S, 330025S, 30030S, 330217S, 330220S, 330225S, 330230S, 330420S, 330425S, & 330430S
Reason for Recall
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.
Distribution Pattern
CA, CO, CT, ID, KS, MA, MD, MN, MO, MS, NC, NY, OH, OR, PA, SD, VA, WA & WI
Code Information
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