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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20 апр. 2018 г. BD PosiFlush™ Heparin Lock Flush Syringes. 306509 306510
BD_Posi-Flush Brochure Option -V8 (I) (with updated CTA no)
to help reduce complications and improve patient care. BD VAM assessments establish the baseline 5 mL BD PosiFlush™ Heparin Lock Flush Syringe 50 usp units/5 ...
BD PosiFlushTM Pre-Filled Flush Syringes
BD PosiFlush™ helps reduce the risk of catheter related bloodstream BD Medical. The Danby Building. Edmund Halley Road. Oxford Science Park. OXFORD OX4 4DQ.
BD PosiFlush™
BD Luer-Lok™ Tip Cap: Tighter seal for closure integrity helping prevent touch contamination. Clear labelling helps reduce the risk of medication errors.
BD PosiFlush™ Prefilled Saline Syringe Supply Update
Dear BD Valued Customer. We would like to provide you with confidence that BD is working diligently to support your prefilled flush syringe needs through our
BD Medical Medical Surgical Systems Catalogue Canadian Version
BD Activation-Assist™ technology for fast and easy needle tip shielding more than twice as many BD PosiFlush 3 mL size syringes into a 5.1 L In-Room ...
BD Medical – Recall of heparin lock flush and normal saline syringes
20 апр. 2018 г. The BD PosiFlush heparin lock flush syringe is intended to help maintain patency by locking vascular access devices. • The BD pre-filled ...
Think BD PosiFlush™ Syringes filled with Saline.
BD PosiFlush™ SP Syringes are not intended for use on a sterile field. Page 3. Silicone Lubricant. Medical-grade silicone oil is applied to the stopper and
TABLE OF CONTENTS
2 февр. 2017 г. The 0.9% Sodium Chloride Injection USP
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20 Apr 2018 bd.com. URGENT MEDICAL DEVICE RECALL. BD POSIFLUSH™ HEPARIN LOCK FLUSH ... in Attachment B to aid you with the identification of the.
BD PosiFlush Recall
16 Apr 2020 BD is conducting a voluntary medical device recall for multiple lots of the BD PosiFlush™ SF. (Sterile Field) Saline Flush Syringe 10mL ...
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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.
URGENT MEDICAL DEVICE RECALL
16 Apr 2020 BD is conducting a voluntary medical device recall for multiple lots of the BD PosiFlush™ SF. (Sterile Field) Saline Flush Syringe 10mL ...
Briefvorlage BD GmbH mit Logo
20 Apr 2018 bd.com. URGENT MEDICAL DEVICE RECALL. BD POSIFLUSH™ HEPARIN LOCK FLUSH ... in Attachment B to aid you with the identification of the.
BD PosiFlushTM - Because so much is on the line
The BD PosiFlush™ Prefilled Saline Syringe is a solution that is part of the BD Organisation for Standardisation (ISO) 13485 standard on Medical.
Think BD PosiFlush™ Syringes filled with Saline.
BD PosiFlush™ SP Syringes filled with Saline
BD Medical – Recall of heparin lock flush and normal saline syringes
20 Apr 2018 The BD PosiFlush heparin lock flush syringe is intended to help maintain patency by locking vascular access devices. • The BD pre-filled normal ...
AUG 2 6 2004 000016
6 Feb 2004 USP BD Posiflush SF Pre-Filled Flush Syringe was modified by changing the current ... 1976 the enactment date of the Medical Device.
BD_Posi-Flush Brochure Option -V8 (I) (with updated CTA no)
to provide clinical benefits to help improve patient care manufacture over 14 billion BD PosiFlush™ Sterile Path Syringes. Saline and syringes.
BD Medical
1 Becton Drive
Franklin Lakes, NJ 07417
USA bd.comMDS-20-1971-FA Page 1 of 2
URGENT MEDICAL DEVICE RECALL
BD PosiFlush™ SF Saline Flush Syringe 10mL
Date: April 16, 2020
Product Name
UDI Catalog
(Ref) No.Lot No. Exp. Date Shelf Box
Quantity
BD PosiFlush™ SF
Saline Flush
Syringe 10mL
50382903065535
306553
8353952
9011582
9017875
9024676
9045702
9060999
9079716
9127571
9143529
9156595
9163601
2021-12-31
2021-12-31 2021
-12-31 2022
-01-31 2022
-01-31 2022
-02-28 2022
02 -28 2022
-02-28 2022
-04-30 2022
-05-31 2022-05-31 30
For the Attention of:
Patient, Consumer
Description of the problem and health hazard(s):
BD is conducting a voluntary medical device recall for multiple lots of the BD PosiFlush ™ SF (Sterile Field) Saline Flush Syringe 10mL identified in the Table above. This product has been confirmed to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field. While the sterility of the outer surface of the syringe may be compromised, the saline solution and the sterile path of the syringe are not impacted. When used in a sterile field, the compromised sterility due to holes in the packaging may increasethe risk of infection to a patient, potentially leading to medical intervention and/or life-threatening
injury. If the issue is identified prior to use and the syringe is discarded per standard clinical practice, this may lead to a delay or interruption of treatment and user dissatisfaction or annoyanceThis recall affects the catalog and specific lot numbers referenced in this notification. This recall
does not affect any other products or lots. The lot number can be found on the syringe and case label.There have been no repo
rts of adverse events, injuries or deaths related to this recall to date.BD Medical
1 Becton Drive
Franklin Lakes, NJ 07417
USA bd.comMDS-20-1971-FA Page 2 of 2
BD continues to manufacture the BD PosiFlush™ SF Saline Flush Syringe product and replacement orders will be prioritized. As BD does not have an alternative sterile product, this may cause a slight delay in the fulfillment of replacement product. BD understands that supply interruptions can impactour customers' ability to provide the best care for their patients and takes this matter very seriously.
IfBD product is not available,
customers may look for an equivalent sterile prefilled product in the marketplace. Lastly, as an alternate practice, clinicians may choose to draw up normal saline for asterile field using a sterile syringe and sterile needle as described in the "Association of Surgical
Technologists Guidelines for Safe Medication Practices in the Perioperative Area" and following their hospital guidelines. BD has taken immediate action to maximize production for this product to help reduce the impact to our customers.Please Take the Following Actions:
1. Please verify if you have the affected recalled product. To determine if you have the affected
recalled product, please review the catalog and lot number on the shelf box.2. If you have individual syringes outside of the shelf box you need to verify the catalog and lot
number.3. Discard all product subject to the recall. If you don"t have any of the catalog and lot numbers
indicated on the table included in Attachment A, your product is not affected by this recall.4. If you have the recalled product, or additional questions regarding this recall, please contact BD
at 888-364-2985 between 8 AM and 5 PM ET Monday through Friday. BD will assist you with instructions on how to obtain product replacement at no charge.5. Report any adverse health consequences experienced with the use of this product to BD.
Events may also be reported to the FDA's MedWatch Adverse Event Reporting program via:Web: MedWatch web
site at www.fda.gov/medwatchPhone: 1
-800-FDA-1088 (1-800-332-1088)Mail: MedWatch, HF
-2, FDA, 5600 Fisher's Lane, Rockville, MD 20852-9787 BD is committed to advancing the world of health. Our primary objectives are patient and user safety and providing you with quality pro ducts. 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,
Klaus Hoerauf, MD Gail Griffiths
VP Medical Affairs Sr. Director Regulatory ComplianceBD Medication Delivery Solutions BD US Region
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