3M Deutschic:md GmbH Urgent Field Safety Notice Name of the

3M Deutschic:md GmbH
Membranes Business Uni!
Öhder Straße 28
42289 Wuppertal
Germany
3M
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+49 (0)202 6099-0
+49 (0)202 6099-241
Internet: www.membrana.com
E-Mail: [email protected]
WEEE-Reg.-Nr. OE 36963167
VAT-10: OE 120679179
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Urgent Field Safety Notice
Name of the affected product: SelectiCure® L 19
FSCA-identifier: FSN 2016-01
Type of action: voluntary recall
Date: October 181h, 2016
Attention: 3M Customers
3M is conducting a voluntary recall (Field Safety Corrective Action) of the SelectiCure L19 hemofilters. This
. voluntary recall is a precautionary measure. No incidents from the market have been reported.
Details on affected devices:
The following product and Iot numbers are in scope of this FSCA:
Product
REF (Reference)
SelectiCure® L 19
AX1000
Lot number
309014217
309014218
309014219
309014220
Description of the problem:
Expiry dates are based upon product performance. The SelectiCure L19 is Iabeiied as having 3 year shelf life due
to first evaluation of data after three years of accelerated aging. Real-time and accelerated aging tests have been
started simultaneously. Results from 3 year real-time aging studies are completed and show that the results are out
of specification for the albumin sieving coefficient.
The defined shelf life of three years can therefore not be supported by this data.
Potential hazard and risk for the patient:
An out of specification result for albumin permeability may be associated with either hypoalbuminemia or with reduced
efficacy of the filter.
· Action to be taken by the user:
1.
Piease check your inventory for the product and Iot numbers affected by this voluntary recall (see table
above). lmmediately stop the distribution and use of affected products.
2.
Piease separate all products affected by the voluntary recall in a safe place, so that a further distribution
and use is excluded .
3.
Piease fill out the enclosed feedback form "Reca/1 Confirmation Form". Piease send the completed "Reca/1
Confirmation Form" until2016-11-02 to Fax: +49 202 6099 301 or email: [email protected]. For
return of the products, please contact the sales department of 3M Deutschland GmbH, Membranes
Business Unit "Mr. F. Bonn, Oehder Str. 28, D-42289 Wuppertal, Germany, email: [email protected], Tel.:
+49 202 6099 670" to initiate the return.
Sitz: 41453 Neuss · Handelsregister: 8 1878 Amtsgericht Neuss
Geschäftsführer: Dr. John Banovetz, Prof. Dr. Joerg Dederichs, Michael Peters, Rob Schokker
Vorsitzender der Geschäftsführung: Dr. John Banovetz · Vorsitzender des Aufsichtsrates: Günter Gressler
EUR Konto Nr. 6555205 00 · BLZ 300 700 10 · Deutsche Bank Düsseldorf · IBAN DE88 3007 0010 0655 5205 00 · Swift Code DEUTDEDDXXX
USO Konto Nr. 6555205 01 · BLZ 300 700 10 · Deutsche Bank Düsseldorf · IBAN DE61 3007 0010 0655 5205 01 · Swift Code DEUTDEDDXXX
3M Deutschland GmbH
4.
page 2
With regard to patients who have already been treated with the products affected by this voluntary recall,
no special measures are necessary.
Transmission of this Field Safety Notice:
Piease pass this notice on immediately all departments who might use or order the concerned products. Moreover,
ensure that the information is provided to any organization where the concerned products potentially have been
distributed .
Thank you for your immediate attention and cooperation . We apologize for any inconvenience this situation may
cause.
Contact reference person:
lf you have questions, please contact the undersigned .
The undersigned confirms that this notice has been reported to the competent authority.
3M Deutschland GmbH
Membranes Business Unit
Öhder Straße 28
42289 Wuppertal
Germany
3M Deutschland GmbH
page 3
Recall Confirmation Form
Piease complete this form, even if you do not have any of the concerned products and send this form back to the
following:
Fax no.: +49 202 6099-301
or
email: [email protected]
1. We acknowledge receipt of the recall information from 3M Deutschland GmbH
2. Piease mark accordingly:
D
We do not have any of the affected products in stock
D
We will return the following products:
Device name
REF (Reference)
LOT Number
Quantity
309014217
309014218
SelectiCure® L 19
AX1000
309014219
309014220
Note: don't /eave cel/s blank, but mention "none" in case no products were identified at your site.
Company:
Address:
Contact name:
Contact phone number:
Contact email address:
Date and signature:

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