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Medline Probe Cover Kits containing sterile Ultrasound Gel… recallZ-2162-2023 · MEDLINE INDUSTRIES, LP - Northfield · initiated May 18, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from MEDLINE INDUSTRIES, LP - Northfield or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Device Design

What the company is doing

Medline distributed their recall notices to their consignees beginning on 05/18/2023 by letter. The notices explained the problem, and the risk and requested the destruction of the products. Distributors were directed to notify their consignees, have the customers document and destroy any affected product, and include your customers quantities on the response form. Beginning on 05/23/2023, Medline issued another notice to a separate group of consignees requesting that the kits be over labeled. Distributors were directed to notify the customers and have them return any affected product to the distributor for collection and return to Medline. Questions: please contact the Recall Department at 866-359-1704

Recall details

Recall number
Z-2162-2023
Status
Open, Classified
Initiated by the company
May 18, 2023
Posted by the FDA
Jul 20, 2023
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
# included in 3,740,814 units total
Product code
OES
Distribution
Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

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

Code information (models, lots, serial numbers)

Show the full code information (2k characters)

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

Devices named in this recall

19 devices in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 92466).

Sources and updates

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