Z-2317-2023 Class II Ongoing

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. (54) KIT STC PLASTIC FREE FLAP, Model Number: DYNJ909031; b. BREAST, Model Number: DYNJ904598B; c. BREAST DBL PROCED SUPPLEMENT, Model Number: DYNJ63893; d. BREAST PACK, Model Number: DYNDH1306; e. BRST BX TRAY, Model Number: DYNDH1389B; f. CMC BREAST BIOPSY TRAY-LF, Model Number: DYNJ61084A; g. DBD-DIEP PACK, Model Number: DYNJ60669F; h. DBD-FREE FLAP, Model Number: DYNJ907802; i. DBD-FREE FLAP PACK, Model Number: DYNJ83286; j. DBD-MAJOR BREAST, Model Number: DYNJ905004B; k. DBD-PLASTICS FREE FLAP, Model Number: SYNJ910024A; l. DELNOR SIMPLE PLASTIC PACK, Model Number: DYNJ82250; m. DIEP, Model Number: DYNJ905702C, DYNJ905702D; n. DIEP FLAP CDS, Model Number: DYNJ904762D; o. DIEP PACK, Model Number: DYNJ60669C, DYNJ60669D; p. FH BREAST FLAP PACK, Model Number: DYNJ58272C, DYNJ58272D; q. FLAP KIT, Model Number: DYNJ900845B; r. FLAP PACK, Model Number: DYNJ48191G, DYNJ48191I, DYNJ48191J, DYNJ60224B; s. FLAP RECONSTRUCTION PACK-LF, Model Number: DYNJ0378388P; t. FREE FLAP, Model Number: DYNJ906823A, DYNJ906823B; u. FREE FLAP 1 PACK, Model Number: DYNJ82660; v. FREE FLAP 2 PACK, Model Number: DYNJ82659; w. FREE FLAP BASIC SET-UP PK, Model Number: DYNJ0991320L; x. FREE FLAP CDS, Model Number: CDS983996B; y. FREE FLAP CUSTOM PACK B, Model Number: DYNJ82736; z. FREE FLAP DONOR, Model Number: DYNJ44483B; aa. FREE FLAP PACK, Model Number: DYNJ83286; bb. FREE FLAP PACK-LF, Model Number: DYNJ0271254O, DYNJ20495I, DYNJ42833A, DYNJ42833B, PHS656679003; cc. FREE FLAP RECIPIENT, Model Number: DYNJ44484D, DYNJ44484F; dd. MAIN FLAP, Model Number: DYNJ908264; ee. MAJOR BREAST, Model Number: DYNJ905004A, DYNJ908890; ff. MINOR BREAST, Model Number: DYNJ905002B, DYNJ908892; gg. PK GEN BREAST RESTON, Model Number: DYNJ84305; hh. PLASTIC DIEP PACK, Model Number: DYNJ81727, DYNJ81727A; ii. PLASTIC FREE FLAP, Model Number: DYNJ67367, DYNJ67367A; jj. PLASTIC FREE FLAP PACK, Model Number: DYNJ82758; kk. PLASTIC MICROVASCULAR, Model Number: DYNJ908181, DYNJ908181A, DYNJ908181B; ll. PLASTIC PACK, Model Number: DYNJ35262A; mm. PROCEDURE PACK, Model Number: DYNJ55063; nn. RO-DIEP PACK, Model Number: DYNJ82393; oo. SDS MN BREAST PACK, Model Number: DYNJ57719C, DYNJ57719D; pp. VNUS RFS PROCEDURE PACK, Model Number: DYNJ39508A;

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNJ909031, UPC Number: 019532725061. b. Model Number: DYNJ904598B, UPC Number: 088994294635. c. Model Number: DYNJ63893, UPC Number: 019348977156. d. Model Number: DYNDH1306, UPC Number: 088994277152. e. Model Number: DYNDH1389B, UPC Number: 019348944918. f. Model Number: DYNJ61084A, UPC Number: 019348969202. g. Model Number: DYNJ60669F, UPC Number: 019532728956. h. Model Number: DYNJ907802, UPC Number: 019348989000. i. Model Number: DYNJ83286, UPC Number: 019532725665. j. Model Number: DYNJ905004B, UPC Number: 019348978258. k. Model Number: SYNJ910024A, UPC Number: 019348937448. l. Model Number: DYNJ82250, UPC Number: 019532718175. m. Model Number: DYNJ905702C, UPC Number: 019532700467; Model Number: DYNJ905702D, UPC Number: 019532717382. n. Model Number: DYNJ904762D, UPC Number: 019532725881. o. Model Number: DYNJ60669C, UPC Number: 019532702362; Model Number: DYNJ60669D, UPC Number: 019532721717. p. Model Number: DYNJ58272C, UPC Number: 019348989552; Model Number: DYNJ58272D, UPC Number: 019532714511. q. Model Number: DYNJ900845B, UPC Number: 088994263442. r. Model Number: DYNJ48191G, UPC Number: 019348947660; Model Number: DYNJ48191I, UPC Number: 019532705781; Model Number: DYNJ48191J, UPC Number: 019532725503; Model Number: DYNJ60224B, UPC Number: 019348987735. s. Model Number: DYNJ0378388P, UPC Number: 019532708997. t. Model Number: DYNJ906823A, UPC Number: 019348989447; Model Number: DYNJ906823B, UPC Number: 019532702707. u. Model Number: DYNJ82660, UPC Number: 019532719933. v. Model Number: DYNJ82659, UPC Number: 019532719932. w. Model Number: DYNJ0991320L, UPC Number: 019532702854. x. Model Number: CDS983996B, UPC Number: 088994213130. y. Model Number: DYNJ82736, UPC Number: 019532720755. z. Model Number: DYNJ44483B, UPC Number: 088994281894. aa. Model Number: DYNJ83286, UPC Number: 019532725665. bb. Model Number: DYNJ0271254O, UPC Number: 019348956435; Model Number: DYNJ20495I, UPC Number: 019348956435; Model Number: DYNJ42833A, UPC Number: 088827750399; Model Number: DYNJ42833B, UPC Number: 019348988033; Model Number: PHS656679003, UPC Number: 088994204000. cc. Model Number: DYNJ44484D, UPC Number: 088994281895; Model Number: DYNJ44484F, UPC Number: 019348948834. dd. Model Number: DYNJ908264, UPC Number: 019532702011. ee. Model Number: DYNJ905004A, UPC Number: 088994291171, Model Number: DYNJ908890, UPC Number: 019532720339. ff. Model Number: DYNJ905002B, UPC Number: 019532731686, Model Number: DYNJ908892, UPC Number: 019532720403. gg. Model Number: DYNJ84305, UPC Number: 019532734981. hh. Model Number: DYNJ81727, UPC Number: 019532713711; Model Number: DYNJ81727A, UPC Number: 019532727789. ii. Model Number: DYNJ67367, UPC Number: 019348989571; Model Number: DYNJ67367A, UPC Number: 019532723070. jj. Model Number: DYNJ82758, UPC Number: 019532720744. kk. Model Number: DYNJ908181, UPC Number: 019532700174; Model Number: DYNJ908181A, UPC Number: 019532706226; Model Number: DYNJ908181B, UPC Number: 019532724293. ll. Model Number: DYNJ35262A, UPC Number: 019348990343. mm. Model Number: DYNJ55063, UPC Number: 088994252657. nn. Model Number: DYNJ82393, UPC Number: 019532718973. oo. Model Number: DYNJ57719C, UPC Number: 019348976734; Model Number: DYNJ57719D, UPC Number: 019348994582. pp. Model Number: DYNJ39508A, UPC Number: 088994262891.