Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGI

Summary

The FDA issued a Class II for Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel by MEDLINE INDUSTRIES, LP - Northfield. Reason: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications..

Details

Product Description

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIO, Model Number: DYNJ905151A; b. ANGIO/VENO PACK, Model Number: DYNJ58346A; c. ANGIOGRAPHIC PACK, Model Number: DYNJ57442C, DYNJ64081A; d. ANGIOGRAPHY PACK, Model Number: DYNJ65963; e. ANGIOPLASTY PACK-LF, Model Number: DYNJ64655; f. ARTHROGRAM TRAY, Model Number: SPEC0232; g. BASIC CATH/ANGIO, Model Number: DYNJ62591A; h. BASIC PACK, Model Number: DYNJ39752A; i. C.I.C.N. ANGIO PACK, Model Number: DYNJ53064B; j. CATH ANGIO PACK, Model Number: DYNJ64050; k. DBD-KIT NEURO CAROTID SETUP, Model Number: DYKMBNDL148; l. DBS PACK-LF, Model Number: DYNJ0878178I; m. GENERAL ANGIO PACK, Model Number: DYNJ57760A; n. GHIASSI NEURO ANGIO PACK-LF, Model Number: DYNJ57032C; o. IR NEURO PACK, Model Number: DYNJ39198L, DYNJ39198N; p. KIT OR AORTOGRM ANGIOPLAST PHT, Model Number: DYNJ906086A; q. MAIN BASIC NEURO, Model Number: DYNJ908260; r. NEURO ACCESSORY PACK, Model Number: DYNJ66790, DYNJ66790A, DYNJ66790B; s. NEURO CATH PACK, Model Number: DYNJ69129, DYNJ83090; t. NEURO IR PACK, Model Number: DYNJ35066I, DYNJ35066J, DYNJ60701A, DYNJ60701B, DYNJ60701C; u. NEURO PACK, Model Number: DYNJ43934A, DYNJ61798D, DYNJ66241, DYNJ66241A, DYNJ66241B, DYNJ66241C, DYNJ66241D, DYNJ68956A, DYNJ68956B; v. NEURO RADIOLOGY PACK, Model Number: DYNJ51107A, DYNJ59903A, DYNJ59903B; w. NEURO TRAY, Model Number: DYNJ67075, DYNJ67075A; x. PACK PERCUTANEOUS ANGIO CHRG, Model Number: DYNJ60112A; y. PEDI ANGIO PACK-LF, Model Number: PHS41743B; z. PEDIATRIC CATH ANGIO PACK, Model Number: DYNJ54755C; aa. RADIOLOGY NEURO DRAPE PAC, Model Number: DYNJ61449; bb. RO-DIEP PACK, Model Number: DYNJ82393A;

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: DYNJ905151A, UPC Number: 019348981341. b. Model Number: DYNJ58346A, UPC Number: 019348977463. c. Model Number: DYNJ57442C, UPC Number: 019348920853; Model Number: DYNJ64081A, UPC Number: 019348927374. d. Model Number: DYNJ65963, UPC Number: 019348930770. e. Model Number: DYNJ64655, UPC Number: 019348921040. f. Model Number: SPEC0232, UPC Number: 088827750741. g. Model Number: DYNJ62591A, UPC Number: 019348979331. h. Model Number: DYNJ39752A, UPC Number: 088438990723. i. Model Number: DYNJ53064B, UPC Number: 019348978916. j. Model Number: DYNJ64050, UPC Number: 019348978046. k. Model Number: DYKMBNDL148, UPC Number: 019348947839. l. Model Number: DYNJ0878178I, UPC Number: 019348956435. m. Model Number: DYNJ57760A, UPC Number: 019348922023. n. Model Number: DYNJ57032C, UPC Number: 019348945147. o. Model Number: DYNJ39198L, UPC Number: 019348956435 Model Number: DYNJ39198N, UPC Number: 019532710200. p. Model Number: DYNJ906086A, UPC Number: 019348920868. q. Model Number: DYNJ908260, UPC Number: 019532701744. r. Model Number: DYNJ66790, UPC Number: 019348938243; Model Number: DYNJ66790A, UPC Number: 019348992247; Model Number: DYNJ66790B, UPC Number: 019532709926. s. Model Number: DYNJ69129, UPC Number: 019348989241; Model Number: DYNJ83090, UPC Number: 019532723093. t. Model Number: DYNJ35066I, UPC Number: 019348956435; Model Number: DYNJ35066J, UPC Number: 019532709107; Model Number: DYNJ60701A, UPC Number: 019348969378; Model Number: DYNJ60701B, UPC Number: 019348987733; Model Number: DYNJ60701C, UPC Number: 019532703379. u. Model Number: DYNJ43934A, UPC Number: 019348973360; Model Number: DYNJ61798D, UPC Number: 019348999263; Model Number: DYNJ66241, UPC Number: 019348932296; Model Number: DYNJ66241A, UPC Number: 019348993803; Model Number: DYNJ66241B, UPC Number: 019532705348; Model Number: DYNJ66241C, UPC Number: 019532709685; Model Number: DYNJ66241D, UPC Number: 019532713837; Model Number: DYNJ68956A, UPC Number: 019348987629; Model Number: DYNJ68956B, UPC Number: 019532709434. v. Model Number: DYNJ51107A, UPC Number: 019348971558; Model Number: DYNJ59903A, UPC Number: 019532704286; Model Number: DYNJ59903B, UPC Number: 019532713120. w. Model Number: DYNJ67075, UPC Number: 019348938847; Model Number: DYNJ67075A, UPC Number: 019532705453. x. Model Number: DYNJ60112A, UPC Number: 019348924703. y. Model Number: PHS41743B, UPC Number: 019348978493. z. Model Number: DYNJ54755C, UPC Number: 019348977837. aa. Model Number: DYNJ61449, UPC Number: 019348956734. bb. Model Number: DYNJ82393A, UPC Number: 019532729232.

Quantity Affected: 15,945 kits

Reason for Recall

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

Type: Voluntary: Firm initiated

Recall Initiated: 2023-05-15

Company