—#201134

Product

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CRMC MINOR IR PROCEDURE PK-LF, Model Numbers: DYNJ61099B, DYNJ61099C; b. CRMC TUNNEL CATH TRAY-LF, Model Numbers: DYNJ61118C, DYNJ61118F; c. CUSTOM ANGIO TRAY, Model Number: DYNJ41649G; d. CUSTOM DUAL LUMEN 8.5 FRENCH CVC KIT, Model Number: ECVC2595; e. CV MINOR CDS, Model Numbers: CDS984100U, CDS984100V; f. CVC 16CM BUNDLE, Model Number: ECVC2225; g. CVC 3L 7F 20CM VANTEX, Model Number: ECVC7265A; h. CVC BUNDLE, Model Number: ECVC3235; i. CVC BUNDLE 16CM, Model Number: ECVC2335; j. CVC BUNDLE 20CM 3L, Model Number: ECVC5120B; k. CVC BUNDLE 4L 20CM, Model Number: ECVC5095B; l. CVC BUNDLE 7FR, 3L, 20CM, Model Numbers: ECVC6075, ECVC6460; m. CVC BUNDLE KIT 16CM, Model Number: ECVC2240A; n. CVC BUNDLE KIT 20CM, Model Number: ECVC2001; o. CVC BUNDLE KIT 7F 3L 16CM, Model Number: ECVC7205A; p. CVC BUNDLE KIT 7F 3L 20CM MULTIMED PI, Model Number: ECVC7200; q. CVC BUNDLE KIT OR, Model Number: ECVC2205; r. CVC BUNDLE KIT STANDARD, Model Number: ECVC1970A; s. CVC BUNDLE TRIPLE LUMEN 16CM, Model Number: ECVC5540A; t. CVC BUNDLE VANTEX 7FR, 20CM, 3L, Model Number: ECVC6120; u. CVC BUNDLE, 20CM, 7FR, 3L, Model Number: ECVC6150; v. CVC BUNLDE 4L 20CM, Model Number: ECVC5095B; w. CVC DOUBLE LUMEN 16CM, Model Numbers: ECVC5585A, ECVC5585B, ECVC8105; x. CVC HEART PACK, Model Number: ECVC7360; y. CVC INS BUNDLE W/ MICROPUNCTURE KIT, Model Number: ECVC3755A; z. CVC INSERT BUNDLE 16CM, Model Number: ECVC3260, ECVC7860; aa. CVC INSERT BUNDLE 16CM TRIPLE LUMEN, Model Number: ECVC2895; bb. CVC INSERTION BUNDLE - MULTIMED, Model Number: ECVC5315; cc. CVC INSERTION BUNDLE - VANTEX, Model Number: ECVC5310; dd. CVC INSERTION BUNDLE 20 CM, Model Number: ECVC1555; ee. CVC INSERTION BUNDLE 3L 16CM VANTEX, Model Number: ECVC3286; ff. CVC INSERTION BUNDLE 3L 20 CM VANTEX, Model Number: ECVC3285A; gg. CVC INSERTION BUNDLE 3L, 7FR, 16CM, Model Number: ECVC5560A; hh. CVC INSERTION BUNDLE 8.5FR 4L 16CM, Model Number: ECVC6355; ii. CVC INSERTION BUNDLE W/CATHETER, Model Number: ECVC1525; jj. CVC INSERTION BUNDLE, 20CM, Model Number: ECVC6850; kk. CVC INSERTION MAX BUNDLE 20CM, Model Number: ECVC5525A; ll. CVC INSERTION TRAY 16 CM, Model Number: ECVC1300; mm. CVC KIT WITH CATHETER, Model Number: ECVC885; nn. CVC QUAD-LUMEN PERSONAL PROTECTION KIT, Model Number: ECVC105; oo. CVC TRIPLE LUMEN 16CM, Model Number: ECVC5590B; pp. CVC TRIPLE LUMEN 20CM BUNDLE, Model Number: ECVC2235; qq. CVC TRIPLE LUMEN 7FR 16 CM VANTEX, Model Numbers: ECVC6015A, ECVC6015B; rr. CVC TRIPLE LUMEN 7FR 20CM VANTEX, Model Numbers: ECVC5985A, ECVC5985B; ss. CVC TRIPLE LUMEN BUNDLE, Model Number: ECVC400; tt. CVC TRIPLE LUMEN KIT, Model Number: ECVC465; uu. CVC TRIPLE LUMEN SAFETY BUNDLE, Model Number: ECVC6070; vv. CVC ZONE DEFENSE BUNDLE, Model Numbers: ECVC5385, ECVC6940; ww. DBD-ANGIO DRAPE PACK, Model Number: DYNJ44320J; xx. DBD-CARDIAC EP PACK-LF, Model Number: DYNJ0429185L; yy. DBD-CATH/ANGIO II-LF, Model Number: DYNJ80297; zz. DBD-CRMC TUNNEL CATH TRAY-LF, Model Number: DYNJ61118D; aaa. DBD-CUSTOM ANGIO TRAY, Model Number: DYNJ41649G; bbb. DBD-PERIPHERAL CATHETER 668236-V, Model Number: DYNJ58510A; ccc. DBD-PICC LINE INSERTION PACK, Model Number: DYNJ42531; ddd. DBD-REGIONAL CATHETER KIT, Model Number: PAIN1336; eee. DIALYSIS CATH INSERTION PK-LF, Model Number: DYNJ0198765G; fff. DIALYSIS TRAY, Model Number: DYNJ43060B; ggg. DRAINAGE PROCEDURE PACK, Model Number: DYNJ67149A; hhh. DUAL INSERT BUNDLE, 2L CVC + SHEATH, Model Number: ECVC4985; iii. DUAL INSERTION CVC + SHEATH BUNDLE, Model Number: ECVC2940; jjj. ECMO PACK 2, Model Number: DYNJ82079; kkk. ENDOVASCULAR PACK, Model Number: DYNJ69691; lll. EP DRAPE PACK-LF, Model Number: DYNJ47645B; mmm. EPS PACK, Model Number: DYNJ46545C; nnn. EV LAB PACK, Mo

FDA product code: OES — Cardiac Catheterization 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: DYNJ61099B, UPC Number: 019532711185; Model Number: DYNJ61099C, UPC Number: 019532726200. b. Model Number: DYNJ61118C, UPC Number: 019348946397; Model Number: DYNJ61118F, UPC Number: 019532726198. c. Model Number: DYNJ41649G, UPC Number: 019532727729. d. Model Number: ECVC2595, UPC Number: 10653160332596. e. Model Number: CDS984100U, UPC Number: 019532714613; Model Number: CDS984100V, UPC Number: 019532725205. f. Model Number: ECVC2225, UPC Number: 10653160334385. g. Model Number: ECVC7265A, UPC Number: 10653160345145. h. Model Number: ECVC3235, UPC Number: 10653160336112. i. Model Number: ECVC2335, UPC Number: 10653160332497. j. Model Number: ECVC5120B, UPC Number: 10653160333180. k. Model Number: ECVC5095B, UPC Number: 10653160333173. l. Model Number: ECVC6075, UPC Number: 10653160338437; Model Number: ECVC6460, UPC Number: 10653160335085. m. Model Number: ECVC2240A, UPC Number: 10653160334361. n. Model Number: ECVC2001, UPC Number: 10653160334415. o. Model Number: ECVC7205A, UPC Number: 10653160342007. p. Model Number: ECVC7200, UPC Number: 10653160341680. q. Model Number: ECVC2205, UPC Number: 10653160332435. r. Model Number: ECVC1970A, UPC Number: 10653160346159. s. Model Number: ECVC5540A, UPC Number: 10653160335009. t. Model Number: ECVC6120, UPC Number: 10653160336532. u. Model Number: ECVC6150, UPC Number: 10653160335054. v. Model Number: ECVC5095B, UPC Number: 10653160333173. w. Model Number: ECVC5585A, UPC Number: 10653160333326; Model Number: ECVC5585B, UPC Number: 10653160357711; Model Number: ECVC8105, UPC Number: 10653160357858. x. Model Number: ECVC7360, UPC Number: 10653160346289. y. Model Number: ECVC3755A, UPC Number: 10653160334804. z. Model Number: ECVC3260, UPC Number: 10653160331704; Model Number: ECVC7860, UPC Number: 10653160351191. aa. Model Number: ECVC2895, UPC Number: 10653160332725. bb. Model Number: ECVC5315, UPC Number: 10653160339465. cc. Model Number: ECVC5310, UPC Number: 10653160336211. dd. Model Number: ECVC1555, UPC Number: 10653160331759. ee. Model Number: ECVC3286, UPC Number: 10653160358398. ff. Model Number: ECVC3285A, UPC Number: 10653160358572. gg. Model Number: ECVC5560A, UPC Number: 10653160336501. hh. Model Number: ECVC6355, UPC Number: 10653160336396. ii. Model Number: ECVC1525, UPC Number: 10653160334545. jj. Model Number: ECVC6850, UPC Number: 10653160338819. kk. Model Number: ECVC5525A, UPC Number: 10653160338130. ll. Model Number: ECVC1300, UPC Number: 10653160331780. mm. Model Number: ECVC885, UPC Number: 10653160333562. nn. Model Number: ECVC105, UPC Number: 10653160331773. oo. Model Number: ECVC5590B, UPC Number: 10653160357728. pp. Model Number: ECVC2235, UPC Number: 10653160334378. qq. Model Number: ECVC6015A, UPC Number: 10653160335146; Model Number: ECVC6015B, UPC Number: 10653160357704. rr. Model Number: ECVC5985A, UPC Number: 10653160333371; Model Number: ECVC5985B, UPC Number: 10653160357797. ss. Model Number: ECVC400, UPC Number: 10653160331827. tt. Model Number: ECVC465, UPC Number: 10653160333074. uu. Model Number: ECVC6070, UPC Number: 10653160335863. vv. Model Number: ECVC5385, UPC Number: 10653160336518; Model Number: ECVC6940, UPC Number: 10653160336709. ww. Model Number: DYNJ44320J, UPC Number: 019532713235. xx. Model Number: DYNJ0429185L, UPC Number: 019532704897. yy. Model Number: DYNJ80297, UPC Number: 019532702177. zz. Model Number: DYNJ61118D, UPC Number: 019532710821. aaa. Model Number: DYNJ41649G, UPC Number: 019532727729. bbb. Model Number: DYNJ58510A, UPC Number: 019348981743. ccc. Model Number: DYNJ42531, UPC Number: 088438992673. ddd. Model Number: PAIN1336, UPC Number: 019348951153. eee. Model Number: DYNJ0198765G, UPC Number: 088994205398. fff. Model Number: DYNJ43060B, UPC Number: 088994276585. ggg. Model Number: DYNJ67149A, UPC Number: 019532717903. hhh. Model Number: ECVC4985, UPC Number: 10653160335269. iii. Model Number: ECVC2940, UPC Number: 10653160335351. jjj. Model Number: DYNJ82079, UPC Number: 019532716736. kkk. Model Number: DYNJ69691, UPC Number: 019348997011. lll. Model Number: DYNJ47645B, UPC Number: 019348995283. mmm. Model Number: DYNJ46545C, UPC Number: 019532725042. nnn. Model Number: DYNJ53481D, UPC Number: 019348981257. ooo. Model Number: DYNJ44334M, UPC Number: 019532713311; Model Number: DYNJ44334N, UPC Number: 019532729949. ppp. Model Number: CDS982998C, UPC Number: 019348927943; Model Number: CDS982998D, UPC Number: 019348992377; Model Number: CDS982998F, UPC Number: 019532712690. qqq. Model Number: DYNJ909393, UPC Number: 019532733558. rrr. Model Number: DYNJ66515A, UPC Number: 019348940616. sss. Model Number: ECVC2320, UPC Number: 10653160332480. ttt. Model Number: ECVC2720, UPC Number: 10653160332657. uuu. Model Number: DYNJ57760C, UPC Number: 019532707939. vvv. Model Number: DYNJ65174D, UPC Number: 019348996215. www. Model Number: DYNJ69298, UPC Number: 019348992541. xxx. Model Number: DYNJ57049G, UPC Number: 019532711039; Model Number: DYNJ57049I, UPC Number: 019532720773. yyy. Model Number: DYNJ81213, UPC Number: 019532709427. zzz. Model Number: SYNJ10303C, UPC Number: 019532711889. aaaa. Model Number: DYNJ60343B, UPC Number: 019532721549; Model Number: DYNJ60343C, UPC Number: 019532728504. bbbb. Model Number: DYNJ50694A, UPC Number: 088994269351. cccc. Model Number: DYNJ40215B, UPC Number: 088827791226. dddd. Model Number: ECVC3705, UPC Number: 10653160332893. eeee. Model Number: ECVC1915, UPC Number: 10653160334446. ffff. Model Number: ECVC1915, UPC Number: 10653160334446. gggg. Model Number: STCVC09US, UPC Number: 10653160342939. hhhh. Model Number: STCVC10US, UPC Number: 10653160343097. iiii. Model Number: ECVC6265, UPC Number: 10653160342922. jjjj. Model Number: DYNJ50712D, UPC Number: 019532726792. kkkk. Model Number: DYNJ64976, UPC Number: 019348923712. llll. Model Number: DYNJ36752B, UPC Number: 019532722602; Model Number: DYNJ41989F, UPC Number: 088994276885; Model Number: DYNJ41989G, UPC Number: 019348931080; Model Number: DYNJ61646A, UPC Number: 019532701431; Model Number: DYNJ62037C, UPC Number: 019348921283; Model Number: DYNJ62037D, UPC Number: 019348989369; Model Number: DYNJ67737, UPC Number: 019348942775; Model Number: DYNJ68538, UPC Number: 019348983311; Model Number: DYNJ68729B, UPC Number: 019532702091. mmmm. Model Number: DYNJ66926, UPC Number: 019348938796; Model Number: DYNJ66926A, UPC Number: 019348988735. nnnn. Model Number: DYNJ0950839C, UPC Number: 088994210129. oooo. Model Number: DYNJ69056, UPC Number: 019348988687; Model Number: DYNJ69056A, UPC Number: 019532706129. pppp. Model Number: DYNJ36738G, UPC Number: 019532705416. qqqq. Model Number: ECVC6555, UPC Number: 10653160336341. rrrr. Model Number: DYNJ35164C, UPC Number: 088994249466. ssss. Model Number: DYNJ0537652AG, UPC Number: 019532701767. tttt. Model Number: DYNJ61373A, UPC Number: 019532701469. uuuu. Model Number: ECVC5855B, UPC Number: 10653160355113. vvvv. Model Number: DYNJ52425K, UPC Number: 019532704235; Model Number: DYNJ52425L, UPC Number: 019532707448; Model Number: DYNJ52425M, UPC Number: 019532717718; Model Number: DYNJ52425N, UPC Number: 019532733932. wwww. Model Number: DYNJ69898, UPC Number: 019348999389. xxxx. Model Number: DYNJ38326D, UPC Number: 019348956435; Model Number: DYNJ38326G, UPC Number: 019532723013. yyyy. Model Number: ECVC2650, UPC Number: 10653160334248. zzzz. Model Number: ECVC7095, UPC Number: 10653160339236.

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 #201134. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.