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Urgent Product Recall Notice

Nov 04, 2021

This recall is a continuation of the October 7, 2021 recall.

Re: RECALL - SuperCoreTM Semi-automatic Biopsy Instrument - Additional Lots

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 additional units to your organization:
 

Argon Part Number

Shipping Date

Lot Number

701214090

8/9/2021 & 8/18/2021

11378293

701214090

8/18/2021

11376598

701218200

8/25/2021

11372227

701220150

9/3/2021

11377429

701118060

9/3/2021 & 9/17/2021

11379722

701114090

9/14/2021

11376772

701118090

9/14/2021 & 9/17/2021

11377430

701218090

9/14/2021

11378687

701220150

9/14/2021 & 9/17/2021

11380104

701120150

9/17/2021,9/28/2021, 10/5/2021 & 10/6/2021

11377820

701118090

9/17/2021, 9/28/2021 & 9/30/2021

11378217

701118090

9/17/2021 & 9/30/2021

11383785

701218150

9/28/2021

11377636

701120090

9/28/2021 & 10/6/2021

11378865

701118060

9/30/2021

11383890

701220150

9/30/2021

11384717

701114090

10/5/2021

11382837

701220090

10/6/2021

11381572

701220200

10/6/2021

11382884

701118090

10/8/2021

11383193

701218150

10/8/2021

11383195

701116090

10/8/2021

11388461

701118060

7/15/2021

11371012

701118060

6/10/2021

11361702

701120150

6/25/2021

11366252


The Acknowledgement and Receipt Form at the end 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