FDA-Device2023-07-26Class II

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATH PACK, Model Number DYNJ83105; b) TESIO, Model Number DYNJ83251; c) ANGIOGRAPHY PACK-LF, Model Number DYNJ83508; d) OR ANGIOGRAM PACK-LF, Model Number DYNJ83656; e) FERRELL-DUCAN ANGIO, Model Number DYNJ83696; f) ANGIO KIT PACK, Model Number DYNJ83746; g) M&E ARTERIOGRAM PK, Model Number DYNJ83815; h) ANGIOGRAPHY CV RAD PACK, Model Number DYNJ83918; i) ANGIO PACK, Model Number DYNJ83936; j) ART

MEDLINE INDUSTRIES, LP - Northfield
Hazard

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Sold states
Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.
Affected count
# included in 3,740,814 units total
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATH PACK, Model Number DYNJ83105; b) TESIO, Model Number DYNJ83251; c) ANGIOGRAPHY PACK-LF, Model Number DYNJ83508; d) OR ANGIOGRAM PACK-LF, Model Number DYNJ83656; e) FERRELL-DUCAN ANGIO, Model Number DYNJ83696; f) ANGIO KIT PACK, Model Number DYNJ83746; g) M&E ARTERIOGRAM PK, Model Number DYNJ83815; h) ANGIOGRAPHY CV RAD PACK, Model Number DYNJ83918; i) ANGIO PACK, Model Number DYNJ83936; j) ARTERIOGRAM - SUMMIT PACK, Model Number DYNJ84040; k) ANGIO PACK, Model Number DYNJ84190; l) ANGIO, Model Number DYNJ902507C; m) ANGIO, Model Number DYNJ902507D; n) ANGIO, Model Number DYNJ905151B; o) PACK ANGIOPLASTY CV,8405, Model Number DYNJ906766B; p) (13) STC IVC FILTER/ANGIOGRAM, Model Number DYNJ908249A; q) OR ANGIOGRAM, Model Number DYNJ909267; r) RADIOLOGY PACK #108402-LF, Model Number DYNJVB1000; s) HYBRID OR PACK, Model Number SYNJ10303C

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2162-2023

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