Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CRANIOTOMY CDS-1, Model Numb
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-2191-2023
Action Date
2023-07-26
Status
Ongoing
Category
device
Product Description
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CRANIOTOMY CDS-1, Model Number CDS982889I; b) JOINT INJECTION TRAY, Model Number DYNDH1722; c) LOWER EXTREMITY PACK-LF, Model Number DYNJ0604434X; d) ARTHROSCOPY PACK, Model Number DYNJ44322I; e) SHOULDER ARTHROSCOPY PACK, Model Number DYNJ44348D; f) SHOULDER ARTHROSCOPY PACK, Model Number DYNJ44348F; g) IR ARM PACK, Model Number DYNJ50712C; h) HYBRID PACK, Model Number DYNJ56907D; i) TUNNEL PACK, Model Number DYNJ58127B; j) CRANIOTOMY PACK, Model Number DYNJ61749A; k) CARPAL TUNNEL KIT, Model Number DYNJ63149A; l) ANGIOGRAPHY PACK, Model Number DYNJ65963A; m) ARTHROSCOPY PACK, Model Number DYNJ66402; n) ARTHROSCOPY PACK, Model Number DYNJ66402A; o) ARTHROSCOPY PACK, Model Number DYNJ66402C; p) SHOULDER ARTHROSCOPY PACK, Model Number DYNJ66404; q) SHOULDER ARTHROSCOPY PACK, Model Number DYNJ66404A; r) SHOULDER ARTHROSCOPY PACK, Model Number DYNJ66404B; s) ARTHROSCOPY PACK, Model Number DYNJ68997; t) MURRIETA PACK, Model Number DYNJ69312; u) MURRIETA PACK, Model Number DYNJ69312A; v) SHOULDER ARTHROSCOPY PACK, Model Number DYNJ82077; w) SCO ARTHROSCOPY, Model Number DYNJ906551A; x) US JOINT KIT, Model Number DYNJRA1944; y) HIP FRACTURE NERVE BLOCK, Model Number DYNJRA2085; z) ENS STERILE POUR IMPLANT-LF, Model Number OST011E; aa) ARTHROGRAM TRAY, Model Number PAIN1524C; bb) SHOULDER PACK-LF, Model Number PHS41748D; cc) LOWER EXTREMITY BLOCK PACK-RX, Model Number SPEC0204D; dd) UPPER EXTREMITY BLOCK PACK-RX, Model Number SPEC0205F;
Lot/Code Info: all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number CDS982889I, UDI/DI (EA) 10889942208067, UDI/DI (CS) 40889942208068; b) Model Number DYNDH1722, UDI/DI (EA) 10195327132163, UDI/DI (CS) 40195327132164; c) Model Number DYNJ0604434X, UDI/DI (EA) 10889942763801, UDI/DI (CS) 40889942763802; d) Model Number DYNJ44322I, UDI/DI (EA) 10193489530612, UDI/DI (CS) 40193489530613; e) Model Number DYNJ44348D, UDI/DI (EA) 10889942646722, UDI/DI (CS) 40889942646723; f) Model Number DYNJ44348F, UDI/DI (EA) 10193489530650, UDI/DI (CS) 40193489530651; g) Model Number DYNJ50712C, UDI/DI (EA) 10193489870169, UDI/DI (CS) 40193489870160; h) Model Number DYNJ56907D, UDI/DI (EA) 10193489831566, UDI/DI (CS) 40193489831567; i) Model Number DYNJ58127B, UDI/DI (EA) 10193489482799, UDI/DI (CS) 40193489482790; j) Model Number DYNJ61749A, UDI/DI (EA) 10195327063016, UDI/DI (CS) 40195327063017; k) Model Number DYNJ63149A, UDI/DI (EA) 10193489786477, UDI/DI (CS) 40193489786478; l) Model Number DYNJ65963A, UDI/DI (EA) 10193489992052, UDI/DI (CS) 40193489992053; m) Model Number DYNJ66402, UDI/DI (EA) 10193489352016, UDI/DI (CS) 40193489352017; n) Model Number DYNJ66402A, UDI/DI (EA) 10193489840520, UDI/DI (CS) 40193489840521; o) Model Number DYNJ66402C, UDI/DI (EA) 10193489938456, UDI/DI (CS) 40193489938457; p) Model Number DYNJ66404, UDI/DI (EA) 10193489352078, UDI/DI (CS) 40193489352079; q) Model Number DYNJ66404A, UDI/DI (EA) 10193489840537, UDI/DI (CS) 40193489840538; r) Model Number DYNJ66404B, UDI/DI (EA) 10193489941166, UDI/DI (CS) 40193489941167; s) Model Number DYNJ68997, UDI/DI (EA) 10193489874655, UDI/DI (CS) 40193489874656; t) Model Number DYNJ69312, UDI/DI (EA) 10193489929461, UDI/DI (CS) 40193489929462; u) Model Number DYNJ69312A, UDI/DI (EA) 10195327216771, UDI/DI (CS) 40195327216772; v) Model Number DYNJ82077, UDI/DI (EA) 10195327166953, UDI/DI (CS) 40195327166954; w) Model Number DYNJ906551A, UDI/DI (EA) 10195327124083, UDI/DI (CS) 40195327124084; x) Model Number DYNJRA1944, UDI/DI (EA) 10195327133047, UDI/DI (CS) 40195327133048; y) Model Number DYNJRA2085, UDI/DI (EA) 10195327286743, UDI/DI (CS) 40195327286744; z) Model Number OST011E, UDI/DI (EA) 10888277589322, UDI/DI (CS) 40888277589323; aa) Model Number PAIN1524C, UDI/DI (EA) 10195327271602, UDI/DI (CS) 40195327271603; bb) Model Number PHS41748D, UDI/DI (EA) 10193489784794, UDI/DI (CS) 40193489784795; cc) Model Number SPEC0204D, UDI/DI (EA) 10193489302981, UDI/DI (CS) 40193489302982; dd) Model Number SPEC0205F, UDI/DI (EA) 10193489212884, UDI/DI (CS) 40193489212885
Quantity Affected: 19940 units
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-2191-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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