[PDF] Briefvorlage BD GmbH mit Logo bd.com. URGENT MEDICAL DEVICE





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URGENT MEDICAL DEVICE RECALL URGENT MEDICAL DEVICE RECALL

16 апр. 2020 г. BD is conducting a voluntary medical device recall for multiple lots of the BD PosiFlush™ SF (Sterile ... Please assist BD with assuring these ...



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TABLE OF CONTENTS

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Briefvorlage BD GmbH mit Logo

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bd.com. URGENT MEDICAL DEVICE RECALL. BD POSIFLUSH™ PRE-FILLED NORMAL SALINE SYRINGE If you require further assistance please contact: Contact.



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MDS-19-1701 Page 1 of 3

BD

2100 Derry Road West, Unit 100

Mississauga, Ontario L5N 0B3

bd.com

URGENT MEDICAL DEVICE RECALL

BD POSIFLUSH™ PRE-

FILLED NORMAL SALINE SYRINGE

October 2019

For the Attention of:

Customer

Description of the problem and health hazard(s):

BD is initiating a voluntary recall for the BD Posiflush™ Pre-Filled Normal Saline Syringes catalog

and lot numbers referenced in the table above. The lots are being recalled as BD has become aware that a limited number of syringes labeled "Posiflush Experimental Product" and "Not for Human Use" being mixed with standard BD Posiflush™ Pre-Filled Normal Saline Syringes. BD has not received any reports of related adverse events and has confirmed that these syringes were manufactured and sterilized in accordance with our normal manufacturing process, perform as intended and do not pose any risk to health. BD is voluntarily recalling these devices to avoid confusion on the part of the user.

Distribution of the affected lot

s was between June - September, 2019. Our records indicate you may have received the affected product.

Please Take the Following Actions:

1. Immediately review your inventory for the specific Catalogue (Ref) and lot numbers listed

above. Destroy all product subject to the recall following your institution's process for destruction.

2. Share this recall notification with all users of the product within your facility to ensure that

they are also aware of this recall.

3. Complete the attached Customer Response Form and return to the contact noted on the

form whether or not you have any of the impacted material so that your receipt of this notification may be acknowledged

Actions Taken by BD:

1. Corrective actions have been initiated to prevent recurrence of the identified root cause.

2. Your distributor will issue credit to you for product destroyed, once they receive the

response form.

Contact Information:

If you require further assistance, please contact: Contact Contact Information Customer/Technical support (866) 979-9408

Product Name Cat. No. (Ref) Lot

Nos.

Exp. Date BD Posiflush™ Pre-Filled Normal

Saline Syringes 306547 9142881 30-April-2022

306575 9175971 30-June-2022

MDS-19-1701 Page 2 of 3

BD

2100 Derry Road West, Unit 100

Mississauga, Ontario L5N 0B3

bd.com BD is committed to advancing the world of health. Our primary objectives are patient and user safety and providing you with quality products. We apologize for any inconvenience this issue may have caused you and thank you in advance for helping us to resolve this matter as quickly and effectively as possible.

Sincerely,

For Blair Johnston Patricia Norman Vice President Director Medication Delivery Solutions (MDS) Regulatory Affairs & Quality Management BECTON DICKINSON CANADA INC. BECTON DICKINSON CANADA INC.quotesdbs_dbs26.pdfusesText_32
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