medical Class II Updated 2023-08-09

MEDLINE INDUSTRIES, LP - Northfield recalls Custom Sterile and Non-Sterile Procedural Kits containing Tu

Recalled Product

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CENTRAL LINE INSERT KIT W/O CA, Model Number: CVI3755; b. CENTRAL LINE KIT, Model Number: DYNDC2582, DYNDC2582A; c. CENTRAL LINE PACK-COMPANION, Model Number: DYNJ47215D; d. CENTRAL LINE TRAY, Model Number: DYNJ42902B; e. CENTRAL LINE UNIVERSAL INSERTION, Model Number: CVI3780; f. CLOSURE PACK, Model Number: DYNJ83054A; g. DBD-PICC LINEPACK PCLUI642-LF, Model Number: DYNJ47717A; h. ER CENTRAL LINE KIT, Model Number: P155508B, P155508C; i. HEMODIALYSIS CENTRAL LINE, Model Number: DYNJ63347; j. LINE KIT, Model Number: DYNJ47987A; k. PEDIATRIC CENTRAL LINE KIT, Model Number: DYNJ38885B; l. PK CUST CENTRAL LINE PACK, Model Number: DYNJ60586; m. TRAY LACERATION, Model Number: DYNDL1134A; n. TUNNEL LINE PACK, Model Number: DYNJ67990; o. ULTRASOUND GUIDED IV/MIDLINE K, Model Number: DYNDV2385;

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)

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: CVI3755, UPC Number: 019348981943. b. Model Number: DYNDC2582, UPC Number: 10889942670444; Model Number: DYNDC2582A, UPC Number: 10193489198164. c. Model Number: DYNJ47215D, UPC Number: 088827774302. d. Model Number: DYNJ42902B, UPC Number: 088827779800. e. Model Number: CVI3780, UPC Number: 019348943486. f. Model Number: DYNJ83054A, UPC Number: 019532731051. g. Model Number: DYNJ47717A, UPC Number: 019348945452. h. Model Number: P155508B, UPC Number: 019532709134; Model Number: P155508C, UPC Number: 019532709134. i. Model Number: DYNJ63347, UPC Number: 019348981031. j. Model Number: DYNJ47987A, UPC Number: 088994268310. k. Model Number: DYNJ38885B, UPC Number: 019348946233. l. Model Number: DYNJ60586, UPC Number: 019348952804. m. Model Number: DYNDL1134A, UPC Number: 008019699476. n. Model Number: DYNJ67990, UPC Number: 019348946253. o. Model Number: DYNDV2385, UPC Number: 019348947559.

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