SFDA National Center for Medical Devices Reporting

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Medical Devices Sector قطاع الأجهزة الطبية	NCMDR National Center for Medical Devices Reporting المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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NCMDR Recall

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Reference Number:	mdprc 082 09 18 000
Date submitted:	9/19/2018

Manufacturer:	C R Bard Inc.
Device Type:	HICKMAN Central Venous Catheter
Description:	Catheters, Vascular, Infusion, Central Venous
Medical Device Identifier:	Product Code: 0600570CE Lot Number: HUBT1715
Reason of Field Safety Corrective Action:	BPV has identified that the product code / lot number listed above may be at risk of incorrectly containing a BROVIAC® 6.6 Fr Single-Lumen Central Venous Catheter instead of the HICKMAN 7 Fr Dual-Lumen Central Venous Catheter (Lot HUBT1715).
Remedy Action:	1. Do not use or further distribute the affected product code / lot number. 2. Check all your storage locations for the affected product code / lot number. 3. Immediately remove any identified product code / lot numbers from your shelves and segregate appropriately. 4. Pass this letter to all those who need to be aware of it within your organization. 5. If you have further distributed any of the affected product code /lot number please immediately contact that location, advise them of the recall and have them return the affected product to your facility. 6. Before returning the product to Bard, mark the outside package as “RECALLED PRODUCT” and include the RGA number reference number: FA2018-35.
Athorized Representative/Importer/Distributor:	C.R. BARD Saudi Arabia
Report Source:	NCMDR
Source Ref. Number:	B8F5F4592131B
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	C R Bard Inc..pdf

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