[PDF] [PDF] URGENT MEDICAL DEVICE RECALL - BD

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16 avr 2020 · BD is conducting a voluntary medical device recall for multiple lots of the BD PosiFlush™ SF (Sterile Field) Saline Flush Syringe 10mL identified 

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BD Medical

1 Becton Drive

Franklin Lakes, NJ 07417

USA bd.com

MDS-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 increase

the 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 annoyance

This 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.com

MDS-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 impact

our customers' ability to provide the best care for their patients and takes this matter very seriously.

If

BD 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 a

sterile 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/medwatch

Phone: 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 Compliance

BD Medication Delivery Solutions BD US Region

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