—#201386

Product

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ELECTROPHYSIOLOGY PACK-LF, Model Number: DYNJ0842825D; b. EMANUEL EP TRAY, Model Number: DYNJ49933I, DYNJ49933J; c. ENDO LASER ABLATION PK-LF, Model Number: DYNJ44808G; d. ENDO VASCULAR, Model Number: DYNJ51304B, DYNJ51304C; e. ENDO VASCULAR PACK, Model Numbers: DYNJ0678934D, DYNJ0678934F, DYNJ82567; f. ENDO VASCULAR PACK-LF, Model Number: DYNJ0676055N; g. ENDOVASCULAR, Model Numbers: DYNJ63343A, DYNJ63343B, DYNJ63343D, DYNJ63343F, DYNJ908880; h. ENDOVASCULAR CDS, Model Number: CDS983394I, CDS983394J, CDS983394K; i. ENDOVASCULAR IMF 88370-LF, Model Number: DYNJVB91067; j. ENDOVASCULAR KIT, Model Number: DYNJ906354D, DYNJ906354F; k. ENDOVASCULAR PACK, Model Number: DYNJ0678934I, DYNJ44934F, DYNJ905726C, DYNJ905726D; l. ENDOVASCULAR PACK-LF, Model Number: DYNJ42831F; m. ENDOVASCULAR -TEMPLE, Model Number: DYNJ67750, DYNJ67750A, DYNJ67750B, DYNJ67750C; n. ENDOVENOUS ABLATION PACK, Model Number: DYNJ80489; o. ENDOVENOUS BASIC PACK, Model Number: DYNJ48456C, DYNJ69108A; p. ENDOVENOUS PACK, Model Number: DYNJ83606; q. ENT FREE FLAP, Model Number: SYNJ910018B; r. EP ANGIO PACK, Model Number: DYNJ25749S; s. EP DRAPE PACK-LF, Model Number: DYNJ47645C; t. EP LAB, Model Number: DYNJ59392D, DYNJ59392F; u. EP PACER PACK, Model Number: DYNJ67770; v. EP PACK, Model Number: DYNJ23456K, DYNJ68019, DYNJ81716, DYNJ81716A, DYNJ81716B; w. EP PROCEDURE PACK, Model Number: DYNJ67771; x. EP TRAY, Model Number: DYNJ31928D; y. FEM POP BYPASS PACK-LF, Model Number: DYNJ53480F; z. FEM POP PACK, Model Number: DYNJ67487C; aa. FISTULA PACK, Model Number: DYNJ82711; bb. FISTULA SAVANNAH PACK, Model Number: DYNJ69943A; cc. GENERAL HEART, Model Number: DYNJ907915; dd. GROTH LASER VEIN CDS, Model Number: CDS984193O; ee. GV PERIPHERAL VASCULAR PACK, Model Number: DYNJ46590I, DYNJ46590J, DYNJ46590K; ff. GWINNETT ENDOVASCULAR WSTE MGT, Model Number: DYNJ68198; gg. HCP OPEN HEART ACCESSORY PACK, Model Number: DYNJ51925F; hh. HEART A PACK, Model Number: DYNJ0541930N; ii. HEART FAILURE PACK, Model Number: DYNJ64877B; jj. HEART FAILURE PK, Model Number: DYNJ55528A, DYNJ55528B, DYNJ55528C; kk. HEART PACK, Model Number: DYNJ48424A; ll. HEART VALVE PACK, Model Number: DYNJ58365C, DYNJ58365F, DYNJ58365G, DYNJ58365J; mm. HEART VEIN NYC-ARTERIAL PACK, Model Number: DYNJ62851B; nn. HEART VEIN NYC LASER ABLATION, Model Number: DYNJ62850A; oo. HMT TAVR, Model Number: DYNJ905495D, DYNJ905495F; pp. HMT VEIN PACK, Model Number: DYNJ38756B; qq. HP MINOR VASCULAR, Model Number: DYNJ907571A, DYNJ907571B; rr. INTERVENTIONAL RAD L J-LF, Model Number: DYNJ40215C; ss. INTERVENTIONAL RADIOLOGY, Model Number: DYNJ52756A; tt. INTERVENTIONAL RADIOLOGY PACK, Model Number: DYNJ47138B; uu. IR ANGIOGRAM LIGHT PK, Model Number: DYNJ82858A; vv. IR ANGIOGRAM PACK, Model Number: DYNJ82859A; ww. JVL-PACK VNUS CLOSURE, Model Number: DYNJ66076; xx. KIT CARDIAC ROBOTIC MID CAB, Model Number: DYKMBNDL22C; yy. KIT LB OPEN HEART, Model Number: CDS840487G; zz. KIT MAJOR VASCULAR, Model Number: DYNJ907262, DYNJ907262B; aaa. KIT NEURO CAROTID SETUP, Model Number: DYKMBNDL148A; bbb. KIT OPEN HEART, Model Number: DYNJ906113; ccc. KIT OR AORTOGRM ANGIOPLAST PHT, Model Number: DYNJ906086B; ddd. KIT VASCULAR AAA REPAIR, Model Number: DYKMBNDL23; eee. KIT VASCULAR ACCESS PHT, Model Number: DYNJ906098, DYNJ906098A; fff. KIT VASCULAR CAROTID, Model Number: DYKMBNDL118A; ggg. KIT VASCULAR RF, Model Number: DYNJ906960A; hhh. KT TAVR PACK, Model Number: DYNJ56283C, DYNJ56283D, DYNJ56283F; iii. LASER ABLATION, Model Number: DYNJ48962B; jjj. LASER AND VEIN PACK, Model Number: DYNJ38995C, DYNJ67725; kkk. LASER PACK, Model Number: DYNJ65294; lll. LB OPEN HEART BOX, Model Number: DYNJ905859B; mmm. LEE VEIN PACK, Model Number: DYNJ54906B; nnn. LEG VASCULAR SUPPLY -LF, Model Number: D

FDA product code: OEZ — Cardiovascular Procedure Kit
Device class: Class 2
Medical specialty: Cardiovascular
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: DYNJ0842825D, UPC Number: 019532728861. b. Model Number: DYNJ49933I, UPC Number: 019348947168; Model Number: DYNJ49933J, UPC Number: 019532706561. c. Model Number: DYNJ44808G, UPC Number: 019348987585. d. Model Number: DYNJ51304B, UPC Number: 088994236595; Model Number: DYNJ51304C, UPC Number: 019348946098. e. Model Number: DYNJ0678934D, UPC Number: 019348956435; Model Number: DYNJ0678934F, UPC Number: 019348956435; Model Number: DYNJ82567, UPC Number: 019532719803. f. Model Number: DYNJ0676055N, UPC Number: 019348956435. g. Model Number: DYNJ63343A, UPC Number: 019348929199; Model Number: DYNJ63343B, UPC Number: 019348947045; Model Number: DYNJ63343D, UPC Number: 019348996760; Model Number: DYNJ63343F, UPC Number: 019532708613; Model Number: DYNJ908880, UPC Number: 019532720343. h. Model Number: CDS983394I, UPC Number: 019348981995; Model Number: CDS983394J, UPC Number: 019532706987; Model Number: CDS983394K, UPC Number: 019532729258. i. Model Number: DYNJVB91067, UPC Number: 019348980153. j. Model Number: DYNJ906354D, UPC Number: 019348998657; Model Number: DYNJ906354F, UPC Number: 019532702150. k. Model Number: DYNJ0678934I, UPC Number: 019348999786; Model Number: DYNJ44934F, UPC Number: 019348944613; Model Number: DYNJ905726C, UPC Number: 019348994337; Model Number: DYNJ905726D, UPC Number: 019532716151. l. Model Number: DYNJ42831F, UPC Number: 019348988032. m. Model Number: DYNJ67750, UPC Number: 019348942917, Model Number: DYNJ67750A, UPC Number: 019348983224, Model Number: DYNJ67750B, UPC Number: 019348991204, Model Number: DYNJ67750C, UPC Number: 019532734136. n. Model Number: DYNJ80489, UPC Number: 019532704584. o. Model Number: DYNJ48456C, UPC Number: 019532701586; Model Number: DYNJ69108A, UPC Number: 019532702571. p. Model Number: DYNJ83606, UPC Number: 019532728485. q. Model Number: SYNJ910018B, UPC Number: 019532700730. r. Model Number: DYNJ25749S, UPC Number: 019532705970. s. Model Number: DYNJ47645C, UPC Number: 019532735517. t. Model Number: DYNJ59392D, UPC Number: 019532705357; Model Number: DYNJ59392F, UPC Number: 019532713598. u. Model Number: DYNJ67770, UPC Number: 019348943071. v. Model Number: DYNJ23456K, UPC Number: 019348996776; Model Number: DYNJ68019, UPC Number: 019348946784; Model Number: DYNJ81716, UPC Number: 019532713806; Model Number: DYNJ81716A, UPC Number: 019532720385; Model Number: DYNJ81716B, UPC Number: 019532727726. w. Model Number: DYNJ67771, UPC Number: 019348943072. x. Model Number: DYNJ31928D, UPC Number: 019532733528. y. Model Number: DYNJ53480F, UPC Number: 019348942488. z. Model Number: DYNJ67487C, UPC Number: 019532726074. aa. Model Number: DYNJ82711, UPC Number: 019532720362. bb. Model Number: DYNJ69943A, UPC Number: 019532728463. cc. Model Number: DYNJ907915, UPC Number: 019348994368. dd. Model Number: CDS984193O, UPC Number: 019348937708. ee. Model Number: DYNJ46590I, UPC Number: 019348975763; Model Number: DYNJ46590J, UPC Number: 019348947369; Model Number: DYNJ46590K, UPC Number: 019532709400. ff. Model Number: DYNJ68198, UPC Number: 019348949917. gg. Model Number: DYNJ51925F, UPC Number: 019532715339. hh. Model Number: DYNJ0541930N, UPC Number: 019348971892. ii. Model Number: DYNJ64877B, UPC Number: 019348941589. jj. Model Number: DYNJ55528A, UPC Number: 088994297663; Model Number: DYNJ55528B, UPC Number: 019532704649; Model Number: DYNJ55528C, UPC Number: 019532724820. kk. Model Number: DYNJ48424A, UPC Number: 088827792129. ll. Model Number: DYNJ58365C, UPC Number: 019348945985; Model Number: DYNJ58365F, UPC Number: 019348982057; Model Number: DYNJ58365G, UPC Number: 019348988393; Model Number: DYNJ58365J, UPC Number: 019532701909. mm. Model Number: DYNJ62851B, UPC Number: 019348927121. nn. Model Number: DYNJ62850A, UPC Number: 019348978423. oo. Model Number: DYNJ905495D, UPC Number: 019348983924; Model Number: DYNJ905495F, UPC Number: 019348992493. pp. Model Number: DYNJ38756B, UPC Number: 019348956435. qq. Model Number: DYNJ907571A, UPC Number: 019348992612; Model Number: DYNJ907571B, UPC Number: 019532726241. rr. Model Number: DYNJ40215C, UPC Number: 019532717650. ss. Model Number: DYNJ52756A, UPC Number: 019348941383. tt. Model Number: DYNJ47138B, UPC Number: 088994227421. uu. Model Number: DYNJ82858A, UPC Number: 019532724489. vv. Model Number: DYNJ82859A, UPC Number: 019532724490. ww. Model Number: DYNJ66076, UPC Number: 019348931923. xx. Model Number: DYKMBNDL22C, UPC Number: 019532724096. yy. Model Number: CDS840487G, UPC Number: 019348967442. zz. Model Number: DYNJ907262, UPC Number: 019348938515, Model Number: DYNJ907262B, UPC Number: 019532711641. aaa. Model Number: DYKMBNDL148A, UPC Number: 019532724129. bbb. Model Number: DYNJ906113, UPC Number: 019348965872. ccc. Model Number: DYNJ906086B, UPC Number: 019532704635. ddd. Model Number: DYKMBNDL23, UPC Number: 019348947918. eee. Model Number: DYNJ906098, UPC Number: 019348963877; Model Number: DYNJ906098A, UPC Number: 019348920945. fff. Model Number: DYKMBNDL118A, UPC Number: 019532724067. ggg. Model Number: DYNJ906960A, UPC Number: 019532700259. hhh. Model Number: DYNJ56283C, UPC Number: 019348926872; Model Number: DYNJ56283D, UPC Number: 019532709387; Model Number: DYNJ56283F, UPC Number: 019532721185. iii. Model Number: DYNJ48962B, UPC Number: 088994212967. jjj. Model Number: DYNJ38995C, UPC Number: 019348971314, Model Number: DYNJ67725, UPC Number: 019348942584. kkk. Model Number: DYNJ65294, UPC Number: 019348926426. lll. Model Number: DYNJ905859B, UPC Number: 019348941786. mmm. Model Number: DYNJ54906B, UPC Number: 019348928963. nnn. Model Number: DYNJ905626B, UPC Number: 019348963423. ooo. Model Number: DYNJ81407, UPC Number: 019532711766. ppp. Model Number: DYNJ41100C, UPC Number: 019348989982. qqq. Model Number: DYNJ0678934G, UPC Number: 019348956435. rrr. Model Number: DYNJ902168C, UPC Number: 019348945421. sss. Model Number: DYNJ908687, UPC Number: 019532714092. ttt. Model Number: DYNJ61373, UPC Number: 019348957669. uuu. Model Number: DYNJ901062D, UPC Number: 019348921181; Model Number: DYNJ905641, UPC Number: 019348952766; Model Number: DYNJ905641A, UPC Number: 019532703927; Model Number: DYNJ906371B, UPC Number: 019348981669; Model Number: DYNJ906371C, UPC Number: 019532702146; Model Number: DYNJ906951, UPC Number: 019348929999; Model Number: DYNJ906951A, UPC Number: 019532712835; Model Number: DYNJ908390, UPC Number: 019532708832. vvv. Model Number: CDS840368M, UPC Number: 019348949162; Model Number: CDS840368N, UPC Number: 019532702036; Model Number: CDS840368P, UPC Number: 019532732286. www. Model Number: DYNJ45515D, UPC Number: 019348936735; Model Number: DYNJ81610A, UPC Number: 019532731504. xxx. Model Number: DYNJC9307F, UPC Number: 019348926312; Model Number: DYNJC9307G, UPC Number: 019532703329. yyy. Model Number: DYNJ82988, UPC Number: 019532722220; Model Number: DYNJ82988A, UPC Number: 019532729331. zzz. Model Number: DYNJ82987, UPC Number: 019532722211. aaaa. Model Number: DYNJ0622403O, UPC Number: 088994221921. bbbb. Model Number: DYNJ66916A, UPC Number: 019348999322. cccc. Model Number: DYNJ903705I, UPC Number: 019348997955. dddd. Model Number: DYNJ903706K, UPC Number: 019348999413. eeee. Model Number: DYNJ53433G, UPC Number: 019532704243; Model Number: DYNJ53433I, UPC Number: 019532707449; Model Number: DYNJ53433J, UPC Number: 019532722292. ffff. Model Number: DYNJ44122B, UPC Number: 019348923136. gggg.Model Number: DYNJ904171D, UPC Number: 019348945094; Model Number: DYNJ904171F, UPC Number: 019348943924; Model Number: DYNJ907063A, UPC Number: 019348983381; Model Number: DYNJ908391, UPC Number: 019532708831. hhhh. Model Number: DYNJ60713, UPC Number: 019348952003; Model Number: DYNJ60713A, UPC Number: 019532701206; Model Number: DYNJ68616, UPC Number: 019348983858; Model Number: DYNJ69036, UPC Number: 019348988394. iiii. Model Number: DYNJ0349727D, UPC Number: 019532700015. jjjj. Model Number: DYNJ31148I, UPC Number: 019348956435. kkkk. Model Number: DYNJ61584A, UPC Number: 019348981281. llll. Model Number: CDS984231T, UPC Number: 019348962640. mmmm. Model Number: CDS984241L, UPC Number: 019348996186; Model Number: CDS984241M, UPC Number: 019532716563. nnnn. Model Number: DYNJ63892A, UPC Number: 019532717651. oooo. Model Number: DYNJ62735, UPC Number: 019348968528. pppp. Model Number: 00-401185Q, UPC Number: 019348948908. qqqq. Model Number: DYNJ52056C, UPC Number: 019348936944; Model Number: DYNJ52056D, UPC Number: 019532709613. rrrr. Model Number: DYNJ904261B, UPC Number: 019348947953; Model Number: DYNJ905311D, UPC Number: 019348926126; Model Number: DYNJ906760C, UPC Number: 019348999431; Model Number: DYNJ906760D, UPC Number: 019532724695; Model Number: DYNJ9718008AS, UPC Number: 019348926312; Model Number: CDS981161AC, UPC Number: 019532727643. ssss. Model Number: CDS985105N, UPC Number: 019348990229; Model Number: CDS985105O, UPC Number: 019532703624. tttt. Model Number: DYNJ0450131AI, UPC Number: 019348946612. uuuu. Model Number: DYNJ20888K, UPC Number: 019532736012. vvvv. Model Number: DYNJ23533B, UPC Number: 019348956435; Model Number: DYNJ23533D, UPC Number: 019348947065. wwww. Model Number: CDS983849D, UPC Number: 019348927823, Model Number: CDS983849F, UPC Number: 019532722831. xxxx. Model Number: DYNJ55836A, UPC Number: 019348955285. yyyy. Model Number: DYNJ0149567B, UPC Number: 088827773796; Model Number: DYNJ0149567C, UPC Number: 019532723552. zzzz. Model Number: CDS983513F, UPC Number: 019348984372; Model Number: CDS984355F, UPC Number: 088827777034; Model Number: CDS984355G, UPC Number: 019348948463; Model Number: DYNJ905311F, UPC Number: 019348990224; Model Number: DYNJ905311I, UPC Number: 019532714621; Model Number: DYNJ907607A, UPC Number: 019348987340; Model Number: DYNJ907607B, UPC Number: 019532717419.

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 #201386. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.