Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Medical Posiflush 10mL Saline Flush Syringe.
FDA Recall Z-0066-2015 · Posted 2014-10-14
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Recalling FirmArrow International Inc
Recall StatusTerminated
Product CodeDQY
Date Initiated2014-08-06
Date Terminated2016-10-14
Product Quantity71255
Reason for Recall
The component supplier recalled their 0.9% Sodium Chloride Injection USP BD Posiflush SF Saline Flush Syringe 10mL because some unit packages may exhibit open seals which impact package integrity and potentially product sterility.
Firm Action
Arrow International sent an Urgent Medical Device Recall Notification letter, dated August 6, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use and quarantine any affected product. Customers were instructed to remove the BD pre-filled saline syringe from the exterior of the packaging. To return the BD syringes, customers were instructed to complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service. A customer service representative will contact the customer with a Return Good Authorization (RGA) Number and will provide instructions for the return of producet to Arrow International. All customers were asked to complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507. Attn: Customer Service. Customers with questions were instructed to contact their local sales representative or Customer Service at 1-866-246-6990.
Root Cause
Packaging
Distribution Pattern
Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
K073451PRESSURE INJECTABLE PICCArrow International, Inc. · 2008-01-15K011761MAC TWO-LUMEN CENTRAL VENOUS KIT WITH ARROWG ARD BLUE ANTIMICROBIAL SURFACE AND INTEGRAL HEMOSTASIS VALVE/SIDE PORTArrow Intl., Inc. · 2001-10-31K862056[CENTRAL VENOUS][MULTI-LUMEN] CATHETER W/FLEX TIPArrow Intl., Inc. · 1986-08-25K810675ARROW RADIAL ARTERY CATHETERIZATION SETArrow Intl., Inc. · 1981-03-27K780532PERCUTANEOUS SHEATH INTRODUCER KITArrow Intl., Inc. · 1978-04-21
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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