—#201864

Product

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,

FDA product code: LRO — General Surgery Tray
Device class: Class 2
Medical specialty: General, Plastic Surgery
Affected 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.

Why it was recalled

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

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Medline notified customers beginning on 05/15/2023, via mail and email with letter. Customers with Medline Probe Cover Kits were instructed to check inventory for affected kits, destroy any affected kits, and complete and return the response form. Distributors were instructed to notify their customers and have them document and destroy affected kits. Customers with the non-sterile and sterile procedural kits were instructed to quarantine kits, complete and return the response form and, once updated labels are received, over label and discard the affected ultrasound gel product within the kits. Distributors were instructed to notify customers of the recall and have customers return any affected product for return to Medline. Medline identified additional units of Medline Probe Cover Kits and notified customers on 06/22/2023. Customers were instructed to quarantine kits, complete and return the response form and, once updated labels are received, over label and discard the affected ultrasound gel product within the kits.

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

Timeline

Recall initiated: 2023-05-15
Posted by FDA: 2023-08-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #201864. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.