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Urgent Product Recall Notice

Oct 07, 2021

Re: RECALL - SuperCoreTM Semi-automatic Biopsy Instrument

Argon Medical Devices has received complaints that the SuperCoreTM Semi-automatic Biopsy Instrument is coming apart during shipping or prior to use.

Argon has conducted an internal investigation and tracked the affected parts to a narrow time frame resulting from a specific manufacturing event. The plastic housing and plunger can be separated more easily than normal for the lots manufactured during this time frame.

To ensure continued customer satisfaction, Argon Medical Devices has decided to issue a voluntary recall of the affected lots because of the high rate of reports of unintentional disassembly of these devices.

Our records indicate that we may have shipped the following affected units to your organization:
 

Argon Part Number Lot Number Number of units Shipped
to your facility (boxes of 10)
701118090 11362759 130
701114090 11364350 120
701120200 11366253 160
701216090 11364421 130
701218090 11364247 250
701118090 11364420 1,500
701116090 11362716 60
701214090 11369916 110
701114090 11365643 60
701218090 11372366 150
701118090 11370106 230
701118150 11370107 160
701120150 11367440 150
701218090 11374807 110
701120150 11376374 290
701220200 11378295 40
701220200 11372322 20
701118090 11376074 360
701218150 11373084 90
701116090 11363320 300
701118150 11375663 120
701114090 11374998 60
701114150 11368389 20
701216090 11379724 30
701218200 11377432 60
701116090 11365935 100
701120090 11374411 220
701218150 11377636 50
701220090 11370574 50


The Acknowledgement and Receipt Form at the bottom of this webpage helps us know what device is still in your possession. We request that you complete this form and return it as quickly as possible to our attention. This will allow us to begin staging replacement device(s) to you and minimize interruption to service. It is requested that this form still be completed and returned even if there are none of these devices currently in your possession.

If you have device(s) to return, please reach out to Terumo Medical Canada Inc.

TMCI Customer Service Team via email:  TerumoCanadaCustomer.Admin@terumomedical.com or phone 833.883.7866 to request an RMA# for your return.

All affected devices should be returned to TMCI facility using Recall reference: SuperCoreTM Semi-automatic Biopsy Instrument Recall 2021, Attention: Cristina Lorusso

The mailing address is listed below:
SuperCoreTM Semi-automatic Biopsy Instrument Recall 2021
TERUMO MEDICAL CANADA INC.
10911 KEELE STREET UNITS 2-4
VAUGHAN ON, L6A 5A6.

TMCI will provide credit for your devices once we receive your returned device(s) at the address above. Your assistance in accounting for the affected devices in your possession is greatly appreciated.

If you have any questions about this letter or the recall action it describes please Contact: Cristina Lorusso at cristina.lorusso@terumomedical.com

TMCI is committed to providing our customers with high-quality, effective medical devices. We take this commitment seriously and understand that on rare occasion, corrective actions such as this recall may be necessary to uphold that commitment.

Thank you for choosing to do business with TMCI and we apologize for any inconvenience this action may cause you.

Sincerely,
Kimberly Feitl
Director Quality Systems & Compliance
Terumo Medical Corporation

Argon - SuperCore Product Recall Notice
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