FDA Enforcement Class II Ongoing

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. SHY IR PICC PACK, Model Number: DYNJ57112; b. STANDARD PICC II-LF, Model Number: DYNJSPICC2, PICCNC002; c. SUPERFICAL VENOUS PROCEDURE, Model Number: DYNJ82989; d. SUPERFICIAL VENOUS PROCEDURE, Model Number: DYNJ81267; e. TV IR PICC PACK-LF, Model Number: DYNJ41561D; f. ULTASOUND GUIDED PIV INSERTION, Model Number: IVS3635A; g. ULTRASOUND GUIDED PIV KIT, Model Number: DYNDA2669; h. USG PIV INSERTION KIT, Model Number: DYNDV2480; i. VASCULAR, Model Number: DYNJ907965; j. VASCULAR ACCESS, Model Number: DYNJ901340A; k. VASCULAR ACCESS TRAY, Model Number: DYNJ52606B; l. VASCULAR ACCESS-LF, Model Number: DYNJ905285D; m. VASCULAR ENDO LASER PK, Model Number: DYNJ37445G; n. VASCULAR PACK, Model Number: DYNJ66356F; o. VASCULAR VEIN PACK, Model Number: DYNJ69769; p. VEIN ABLATION, Model Number: DYNJ63268C, DYNJ63268D, DYNJ66079A; q. VEIN ABLATION KIT, Model Number: DYNJ69272; r. VEIN ABLATION PACK, Model Number: DYNJ62889A, DYNJ62889B, DYNJ69288; s. VEIN ABLATION PLUS W CHL, Model Number: DYNJ67115A; t. VEIN CLOSURE, Model Number: DYNJ49180A; u. VEIN CLOSURE PACK, Model Number: DYNJ69976, DYNJ69976A, DYNJ81834; v. VEIN CLOSURE TRAY - NIVC, Model Number: DYNJ44737C; w. VEIN HARVESTING PACK, Model Number: DYNJ82933; x. VEIN LIGATION, Model Number: DYNJ64190B; y. VEIN OHH, Model Number: DYNJ65560C; z. VEIN PACK, Model Number: DYNJ66743B, DYNJ69091A, DYNJ69091B, DYNJ69177, DYNJ69942, DYNJ69942A, DYNJ81120, DYNJ81212A, DYNJ83914; aa. VEIN PACK-LF, Model Number: DYNJ66271B, DYNJ66271D; bb. VEIN PROCEDURE PACK, Model Number: DYNJ62038B, DYNJ81177; cc. VEIN PROCEDURE TRAY, Model Number: DYNJ82581; dd. VENCLOSE PROCEDURE PACK 7CM, Model Number: VC-PPH-6F7A; ee. VENCLOSE PROCEDURE PACK MAVEN, Model Number: VC-PPM-12F; ff. VENCLOSE PROCEDURE PACK, 12CM, Model Number: VC-PP-6F12, VC-PPH-6F12A; gg. VENOUS ABLATION, Model Number: DYNJ44904B, DYNJ44904C; hh. VENOUS ACCESS, Model Number: DYNJ59751B; ii. VENOUS ACCESS PACK, Model Number: DYNJ44421B; jj. VENOUS ACCESS TRAY, Model Number: DYNJ20094L; kk. VENOUS LIGATION PACK, Model Number: DYNJ43981G; ll. VENOUS PACK, Model Number: DYNJ43168, DYNJ43168A, DYNJ43168B, DYNJ56260A, DYNJ56447B, DYNJ62711A, DYNJ66499A, DYNJ66499B, DYNJ80169, DYNJ80169A, DYNJ80692; mm. VNUS PACK, Model Number: DYNJ59246A; nn. WEST VALLEY PICC LINE PACK, Model Number: DYNJ43975A;

Recall: Z-2306-2023 · Reported August 9, 2023

Enforcement

Recall Number: Z-2306-2023
Event ID: 92399
Classification: Class II
Status: Ongoing
Product Type: Devices
Firm: MEDLINE INDUSTRIES, LP - Northfield
Voluntary / Mandated: Voluntary: Firm initiated
Initial Notification: Letter
Report Date: August 9, 2023
Initiation Date: May 15, 2023
Classification Date: August 3, 2023
Address: 3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States

Description

Reason

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

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: DYNJ57112, UPC Number: 088994272159. b. Model Number: DYNJSPICC2, UPC Number: 019348926312; Model Number: PICCNC002, UPC Number: 019348987719. c. Model Number: DYNJ82989, UPC Number: 019532722176. d. Model Number: DYNJ81267, UPC Number: 019532710144. e. Model Number: DYNJ41561D, UPC Number: 088994281163. f. Model Number: IVS3635A, UPC Number: 019348936055. g. Model Number: DYNDA2669, UPC Number: 019348946542. h. Model Number: DYNDV2480, UPC Number: 019348994276. i. Model Number: DYNJ907965, UPC Number: 019348995225. j. Model Number: DYNJ901340A, UPC Number: 088994217977. k. Model Number: DYNJ52606B, UPC Number: 088827776311. l. Model Number: DYNJ905285D, UPC Number: 019532706266. m. Model Number: DYNJ37445G, UPC Number: 019348956435. n. Model Number: DYNJ66356F, UPC Number: 019532716001. o. Model Number: DYNJ69769, UPC Number: 019348997779. p. Model Number: DYNJ63268C, UPC Number: 019532707716; Model Number: DYNJ63268D, UPC Number: 019532713221; Model Number: DYNJ66079A, UPC Number: 019348992307. q. Model Number: DYNJ69272, UPC Number: 019348992033. r. Model Number: DYNJ62889A, UPC Number: 019348997112; Model Number: DYNJ62889B, UPC Number: 019532703095; Model Number: DYNJ69288, UPC Number: 019348992267. s. Model Number: DYNJ67115A, UPC Number: 019532709188. t. Model Number: DYNJ49180A, UPC Number: 088827786356. u. Model Number: DYNJ69976, UPC Number: 019532700130; Model Number: DYNJ69976A, UPC Number: 019532713039; Model Number: DYNJ81834, UPC Number: 019532714785. v. Model Number: DYNJ44737C, UPC Number: 019532727787. w. Model Number: DYNJ82933, UPC Number: 019532721933. x. Model Number: DYNJ64190B, UPC Number: 019532728128. y. Model Number: DYNJ65560C, UPC Number: 019532713681. z. Model Number: DYNJ66743B, UPC Number: 019348994979, Model Number: DYNJ69091A, UPC Number: 019348996976, Model Number: DYNJ69091B, UPC Number: 019532717899, Model Number: DYNJ69177, UPC Number: 019348990219, Model Number: DYNJ69942, UPC Number: 019348999843, Model Number: DYNJ69942A, UPC Number: 019532728462, Model Number: DYNJ81120, UPC Number: 019532708588, Model Number: DYNJ81212A, UPC Number: 019532715986, Model Number: DYNJ83914, UPC Number: 019532731312. aa. Model Number: DYNJ66271B, UPC Number: 019348999891; Model Number: DYNJ66271D, UPC Number: 019532713074. bb. Model Number: DYNJ62038B, UPC Number: 019348989849; Model Number: DYNJ81177, UPC Number: 019532708961. cc. Model Number: DYNJ82581, UPC Number: 019532719865. dd. Model Number: VC-PPH-6F7A, UPC Number: 019348942309. ee. Model Number: VC-PPM-12F, UPC Number: 019348942268. ff. Model Number: VC-PP-6F12, UPC Number: 019348957665; Model Number: VC-PPH-6F12A, UPC Number: 019348942310. gg. Model Number: DYNJ44904B, UPC Number: 019348969532; Model Number: DYNJ44904C, UPC Number: 019348985867. hh. Model Number: DYNJ59751B, UPC Number: 019348969591. ii. Model Number: DYNJ44421B, UPC Number: 088994220519. jj. Model Number: DYNJ20094L, UPC Number: 019532721290. kk. Model Number: DYNJ43981G, UPC Number: 019348922353. ll. Model Number: DYNJ43168, UPC Number: 088827703489; Model Number: DYNJ43168A, UPC Number: 019532708470; Model Number: DYNJ43168B, UPC Number: 019532722452; Model Number: DYNJ56260A, UPC Number: 088994275590; Model Number: DYNJ56447B, UPC Number: 019348946406; Model Number: DYNJ62711A, UPC Number: 019348923301; Model Number: DYNJ66499A, UPC Number: 019348997752; Model Number: DYNJ66499B, UPC Number: 019532724210; Model Number: DYNJ80169, UPC Number: 019532701344; Model Number: DYNJ80169A, UPC Number: 019532716974; Model Number: DYNJ80692, UPC Number: 019532706554. mm. Model Number: DYNJ59246A, UPC Number: 019532703911. nn. Model Number: DYNJ43975A, UPC Number: 088827788244.

Distribution

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

Quantity

148,445 kits