Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATH PACK, Model Number DYNJ83
Summary
The FDA issued a Class II for Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the follo by MEDLINE INDUSTRIES, LP - Northfield. Reason: Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams..
Details
Source
Device Recall
External ID
Z-2162-2023
Action Date
2023-07-26
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number DYNJ83105, UDI/DI (EA)10195327231514, UDI/DI (CS)40195327231515; b) Model Number DYNJ83251, UDI/DI (EA)10195327248659, UDI/DI (CS)40195327248650; c) Model Number DYNJ83508, UDI/DI (EA)10195327273163, UDI/DI (CS)40195327273164; d) Model Number DYNJ83656, UDI/DI (EA)10195327288228, UDI/DI (CS)40195327288229; e) Model Number DYNJ83696, UDI/DI (EA)10195327299125, UDI/DI (CS)40195327299126; f) Model Number DYNJ83746, UDI/DI (EA)10195327300692, UDI/DI (CS)40195327300693; g) Model Number DYNJ83815, UDI/DI (EA)10195327311018, UDI/DI (CS)40195327311019; h) Model Number DYNJ83918, UDI/DI (EA)10195327313807, UDI/DI (CS)40195327313808; i) Model Number DYNJ83936, UDI/DI (EA)10195327318550, UDI/DI (CS)40195327318551; j) Model Number DYNJ84040, UDI/DI (EA)10195327329709, UDI/DI (CS)40195327329700; k) Model Number DYNJ84190, UDI/DI (EA)10195327341961, UDI/DI (CS)40195327341962; l) Model Number DYNJ902507C, UDI/DI (EA)10195327137885, UDI/DI (CS)40195327137886; m) Model Number DYNJ902507D, UDI/DI (EA)10195327336561, UDI/DI (CS)40195327336562; n) Model Number DYNJ905151B, UDI/DI (EA)10195327219963, UDI/DI (CS)40195327219964; o) Model Number DYNJ906766B, UDI/DI (EA)10195327250195, UDI/DI (CS)40195327250196; p) Model Number DYNJ908249A, UDI/DI (EA)10195327240509, UDI/DI (CS)40195327240500; q) Model Number DYNJ909267, UDI/DI (EA)10195327314613, UDI/DI (CS)40195327314614; r) Model Number DYNJVB1000, UDI/DI (EA)10193489800999, UDI/DI (CS)40193489800990; s) Model Number SYNJ10303C, UDI/DI (EA)10195327118891, UDI/DI (CS)40195327118892
Quantity Affected: # included in 3,740,814 units total
Reason for Recall
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Distribution
Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-05-18
Company
Northfield, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 192 device recalls issued in the same week, part of 413 device-related FDA actions this month.
MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (MEDLINE INDUSTRIES, LP - Northfield) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does MEDLINE INDUSTRIES, LP - Northfield have FDA actions?
MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2162-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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