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;
This recall is currently active, issued August 3, 2023. It was issued by Medline Industries, Lp - Northfield.
- Recall Initiated
- May 15, 2023
- Posted
- August 3, 2023
- Recall Number
- Z-2306-2023
- Quantity
- 148,445 kits
- Firm Location
- Northfield, IL
- Official Source
- View on FDA website ↗
Reason for Recall
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.
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: 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.
Root Cause
Nonconforming Material/Component
Action Taken
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.