Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Medical Posiflush 10mL Saline Flush Syringe.

FDA device recall Z-0066-2015 · posted 2014-10-14 · Terminated

Recall details

Recalling firm

Arrow International Inc

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.

Action taken

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

Status

Terminated

Product code

DQY

Quantity affected

71255

Distribution

Nationwide Distribution

Date initiated

2014-08-06

Date posted

2014-10-14

Date terminated

2016-10-14

Location

Reading, PA

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