Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DR. RO

Summary

The FDA issued a Class II for Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel by MEDLINE INDUSTRIES, LP - Northfield. Reason: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications..

Details

Product Description

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DR. ROSEN VEIN PACK, Model Number: DYNJ67517; b. DR. VANBOSSE LOWER EXT PACK, Model Number: DYNJ51416B; c. DRAINAGE TRAY, Model Number: DYNJ42913, DYNJ42913A; d. ECMO PACK, Model Number: DYNJ61243; e. EGG RETRIEVAL PACK, Model Number: DYNJ66291, DYNJ66291A; f. EH TAVR PACK, Model Number: DYNJ57449A; g. ELVS PACK-LF, Model Number: DYNJ26940G; h. ENDO AAA HYBRID CHRG, Model Number: DYNJ60126; i. ENDOVASCULAR OR PACK, Model Number: DYNJ54265; j. ENDOVASCULAR PACK, Model Number: DYNJ59085; k. ENDOVASCULAR PACK-LF, Model Number: DYNJ42831D; l. ENDOVENOUS ABLATION PACK, Model Number: DYNJ53435C; m. ENDOVENOUS BASIC PACK, Model Number: DYNJ48456B; n. ENDOVENOUS CORE PACK, Model Number: DYNJ59168; o. ENDOVENOUS PACK, Model Number: DYNJ58228; p. ENS BIOPSIE THYROIDE-HEJ-LF, Model Number: DYNJ62443; q. EP LAB, Model Number: DYNJ59392C; r. EP MERCY JANESVILLE, Model Number: DYNJ907013; s. EP PACK, Model Number: DYNJ57594A; t. EVAR, Model Number: DYNJ900005L; u. EVLA PACK, Model Number: DYNJ66258; v. EVLT, Model Number: DYNJ62417, DYNJ64336; w. EVLT CORE PACK, Model Number: DYNJ45294; x. EVLT PACK, Model Number: DYNJ38674A, DYNJ45997C, DYNJ56548B, DYNJ65995, DYNJ65995A, DYNJ66005; y. FEM POP PACK, Model Number: DYNJ01964M, DYNJ67487A; z. FETAL OPEN/EXIT, Model Number: DYNJ904069C; aa. FH THORACIC PACK, Model Number: DYNJ58572B, DYNJ58572C; bb. FISTULAGRAM/C-ACCESS PACK, Model Number: DYNJ59657A; cc. FLAP, Model Number: DYNJ905146A; dd. FREE FLAP PACK CTX, Model Number: DYNJ68380C; ee. FREE FLAP PACK-LF, Model Number: DYNJ0271254P; ff. FREE FLAP TRAM ADD ON PACK, Model Number: DYNJ82179; gg. GEL ULTRASOUND 20G FOIL , Model Number: DYNJZ45357; hh. GENERAL USE PACK, Model Number: DYNJ41137B; ii. GU ROBOTIC PACK-LF, Model Number: DYNJ0972464Y; jj. GYN LITHOTOMY, Model Number: DYNJ906579C; kk. HH VARITHENA VEIN PACK, Model Number: DYNJ59500; ll. HH VEIN CLOSURE PACK, Model Number: DYNJ59501; mm. HH VEIN PICC MADISON PACK, Model Number: DYNJ59508; nn. HILLCREST PCNL PACK, Model Number: DYNJ69204B; oo. HL VEIN STRIPPING PACK, Model Number: DYNJ40374A; pp. HYBRID KIT, Model Number: DYNJ905335; qq. HYBRID OR PACK, Model Number: SYNJ10303B; rr. I.R. PACK, Model Number: DYNJ60343A; ss. INTRAUTERINE TRNSFUSION -LF, Model Number: DYNJ9048708F; tt. IR MINI KIT, Model Number: DYNJ44519F; uu. IR NEURO PACK, Model Number: DYNJ39198I; vv. IR PERIPHERAL PACK, Model Number: DYNJ45033A; ww. IR SONO PACK, Model Number: DYNDA2365, DYNDA2365B; xx. JBMH EVAR PACK, Model Number: DYNJ69820; yy. JOHNSON OH ACCESSORY PACK, Model Number: DYNJ51927A; zz. JUDKINS PACK-LF, Model Number: DYNJ0530948AR, DYNJ0586030P; aaa. JVL-PACK TUNNELED, Model Number: DYNJ66065; bbb. KF PACK, Model Number: DYNJ57547, DYNJ58647, DYNJ60127A; ccc. KF PACK 2.0, Model Number: DYNJ69619; ddd. KIDNEY CDS, Model Number: DYNJ903873C; eee. KIDNEY TRANSPLANT, Model Number: DYNJ905682; fff. KIT LAP DONOR NEPHRECTOMY, Model Number: DYKMBNDL173B; ggg. KIT LB OPEN HEART, Model Number: DYNJ902261D, DYNJ904401B; hhh. KT TAVR PACK, Model Number: DYNJ56283B; iii. LARGE PROCEDURE PACK, Model Number: DYNJ35524D; jjj. LASER ABLATION, Model Number: DYNJ80299; kkk. LASER KIT, Model Number: DYNJ64075A; lll. LASER PACK, Model Number: DYNJ39053A; mmm. LINE KIT, Model Number: DYNJ47987B; nnn. LINE PLACEMENT PACK-LF, Model Number: DYNJ0931376F; ooo. LIVER 2018, Model Number: DYNJ905655, DYNJ905655B; ppp. LIVER TRANSPLANT CDS, Model Number: CDS984951D; qqq. LIVER TRANSPLANT PACK, Model Number: DYNJ0271349T; rrr. LONESTAR RF PACK, Model Number: DYNJ83152; sss. MAD PERIPHERAL VASCULAR-LF, Model Number: DYNJ902168D; ttt. MAG FREE FLAP CDS-LF,

Lot/Code Info: All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNJ67517, UPC Number: 019348940782. b. Model Number: DYNJ51416B, UPC Number: 088827774647. c. Model Number: DYNJ42913, UPC Number: 088827701320; Model Number: DYNJ42913A, UPC Number: 019532708060. d. Model Number: DYNJ61243, UPC Number: 019348955091. e. Model Number: DYNJ66291, UPC Number: 019348932808, Model Number: DYNJ66291A, UPC Number: 019348948000. f. Model Number: DYNJ57449A, UPC Number: 088994282753. g. Model Number: DYNJ26940G, UPC Number: 019348954079. h. Model Number: DYNJ60126, UPC Number: 088994295193. i. Model Number: DYNJ54265, UPC Number: 088994247400. j. Model Number: DYNJ59085, UPC Number: 088994293201. k. Model Number: DYNJ42831D, UPC Number: 088994284953. l. Model Number: DYNJ53435C, UPC Number: 019348920086. m. Model Number: DYNJ48456B, UPC Number: 088994273317. n. Model Number: DYNJ59168, UPC Number: 088827776444. o. Model Number: DYNJ58228, UPC Number: 088994283549. p. Model Number: DYNJ62443, UPC Number: 019348967919. q. Model Number: DYNJ59392C, UPC Number: 019348928224. r. Model Number: DYNJ907013, UPC Number: 019348931863. s. Model Number: DYNJ57594A, UPC Number: 088994296321. t. Model Number: DYNJ900005L, UPC Number: 019348930031. u. Model Number: DYNJ66258, UPC Number: 019348932547. v. Model Number: DYNJ62417, UPC Number: 019348965705; Model Number: DYNJ64336, UPC Number: 019348980187. w. Model Number: DYNJ45294, UPC Number: 088827709897. x. Model Number: DYNJ38674A, UPC Number: 019348956435; Model Number: DYNJ45997C, UPC Number: 088994268436; Model Number: DYNJ56548B, UPC Number: 019348981318; Model Number: DYNJ65995, UPC Number: 019348931154; Model Number: DYNJ65995A, UPC Number: 019532706812; Model Number: DYNJ66005, UPC Number: 019348931254. y. Model Number: DYNJ01964M, UPC Number: 019348956435; Model Number: DYNJ67487A, UPC Number: 019348988899. z. Model Number: DYNJ904069C, UPC Number: 019348999549. aa. Model Number: DYNJ58572B, UPC Number: 019348989338; Model Number: DYNJ58572C, UPC Number: 019532714262. bb. Model Number: DYNJ59657A, UPC Number: 019348954461. cc. Model Number: DYNJ905146A, UPC Number: 019348956922. dd. Model Number: DYNJ68380C, UPC Number: 019532734124. ee. Model Number: DYNJ0271254P, UPC Number: 019532708953. ff. Model Number: DYNJ82179, UPC Number: 019532718266. gg. Model Number: DYNJZ45357, UPC Number: 088994237354. hh. Model Number: DYNJ41137B, UPC Number: 088994226087. ii. Model Number: DYNJ0972464Y, UPC Number: 019348978326. jj. Model Number: DYNJ906579C, UPC Number: 019532702356. kk. Model Number: DYNJ59500, UPC Number: 088827775013. ll. Model Number: DYNJ59501, UPC Number: 088827775014. mm. Model Number: DYNJ59508, UPC Number: 088827775130. nn. Model Number: DYNJ69204B, UPC Number: 019532736422. oo. Model Number: DYNJ40374A, UPC Number: 088827755794. pp. Model Number: DYNJ905335, UPC Number: 088994287589. qq. Model Number: SYNJ10303B, UPC Number: 019348937374. rr. Model Number: DYNJ60343A, UPC Number: 019348957383. ss. Model Number: DYNJ9048708F, UPC Number: 019348972521. tt. Model Number: DYNJ44519F, UPC Number: 019348946747. uu. Model Number: DYNJ39198I, UPC Number: 019348956435. vv. Model Number: DYNJ45033A, UPC Number: 019348947580. ww. Model Number: DYNDA2365, UPC Number: 019348951634; Model Number: DYNDA2365B, UPC Number: 019348983644. xx. Model Number: DYNJ69820, UPC Number: 019348998143. yy. Model Number: DYNJ51927A, UPC Number: 088827779416. zz. Model Number: DYNJ0530948AR, UPC Number: 019532714188; Model Number: DYNJ0586030P, UPC Number: 088994294714. aaa. Model Number: DYNJ66065, UPC Number: 019348931918. bbb. Model Number: DYNJ57547, UPC Number: 088994275104; Model Number: DYNJ58647, UPC Number: 088994287545; Model Number: DYNJ60127A, UPC Number: 019348972904. ccc. Model Number: DYNJ69619, UPC Number: 019348995944. ddd. Model Number: DYNJ903873C, UPC Number: 019348946309. eee. Model Number: DYNJ905682, UPC Number: 088827779190. fff. Model Number: DYKMBNDL173B, UPC Number: 019532724075. ggg. Model Number: DYNJ902261D, UPC Number: 088994275524; Model Number: DYNJ904401B, UPC Number: 019348968343. hhh. Model Number: DYNJ56283B, UPC Number: 019348969525. iii. Model Number: DYNJ35524D, UPC Number: 019348976610. jjj. Model Number: DYNJ80299, UPC Number: 019532702193. kkk. Model Number: DYNJ64075A, UPC Number: 019348923132. lll. Model Number: DYNJ39053A, UPC Number: 019348956435. mmm. Model Number: DYNJ47987B, UPC Number: 019348986737. nnn. Model Number: DYNJ0931376F, UPC Number: 019348927150. ooo. Model Number: DYNJ905655, UPC Number: 088827778885; Model Number: DYNJ905655B, UPC Number: 019532713015. ppp. Model Number: CDS984951D, UPC Number: 019348925779. qqq. Model Number: DYNJ0271349T, UPC Number: 019532708969. rrr. Model Number: DYNJ83152, UPC Number: 019532723708. sss. Model Number: DYNJ902168D, UPC Number: 019348986615. ttt. Model Number: CDS982911M, UPC Number: 019348946493. uuu. Model Number: DYNJ68172, UPC Number: 019348949239. vvv. Model Number: CDS980752I, UPC Number: 088994242854; Model Number: DYNJ54285A, UPC Number: 088994276548. www. Model Number: CDS983315G, UPC Number: 088994286443. xxx. Model Number: DYND2673B, UPC Number: 019348956435. yyy. Model Number: DYNJ51705B, UPC Number: 019348987717. zzz. Model Number: DYNJ0248546C, UPC Number: 088994205551; Model Number: DYNJ0248546D, UPC Number: 019532706928. aaaa. Model Number: CDS984379D, UPC Number: 088994272434. bbbb. Model Number: MID0001, UPC Number: 019348938162. cccc. Model Number: DYNJ80141MB, UPC Number: 088994273341. dddd. Model Number: PICC0009A, UPC Number: 088994214185. eeee. Model Number: DYNJ80152MB, UPC Number: 088994273342. ffff. Model Number: DYNJ905002A, UPC Number: 088994291165. gggg. Model Number: DYNJ64439, UPC Number: 019348920048. hhhh. Model Number: DYNJ38326F, UPC Number: 019348956435. iiii. Model Number: DYNJ902281, UPC Number: 088827798141. jjjj. Model Number: NG410A, UPC Number: 088994294588. kkkk. Model Number: DYNJ63892, UPC Number: 019348977143. llll. Model Number: DYNJ69716A, UPC Number: 019532725057. mmmm. Model Number: ARTNC115, UPC Number: 065316035433. nnnn. Model Number: DYNJ63739, UPC Number: 019348975467. oooo. Model Number: DYNJ59201B, UPC Number: 019348931026; Model Number: DYNJ59201C, UPC Number: 019532706202. pppp. Model Number: DYNJ908680, UPC Number: 019532713938. qqqq. Model Number: DYNJ61517, UPC Number: 019348957757. rrrr. Model Number: DYNJ82561, UPC Number: 019532719797. ssss. Model Number: DYNJ54569A, UPC Number: 019348974295. tttt. Model Number: DYNJ60126A, UPC Number: 019348924708. uuuu. Model Number: DYNJ65488B, UPC Number: 019348944364. vvvv. Model Number: DYNJ906902, UPC Number: 019348928093. wwww. Model Number: DYNJ906895C, UPC Number: 019532730355. xxxx. Model Number: DYNDH1165A, UPC Number: 088994261150, 10889942611508. yyyy. Model Number: DYNJ37280C, UPC Number: 088994243165; Model Number: DYNJ56536, UPC Number: 088994265471. zzzz. Model Number: DYNDH1292, UPC Number: 088994274223; Model Number: DYNDH1470B, UPC Number: 019348911124; Model Number: DYNDH1470C, UPC Number: 019532729771.

Quantity Affected: 93,587 kits

Reason for Recall

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

Type: Voluntary: Firm initiated

Recall Initiated: 2023-05-15

Company