PICC Kits with Peel-Away Sheath Component; catheter, intravascular, therapeutic, ultrasound Product Usage: catheter, int

FDA device recall Z-2462-2015 · posted 2015-08-25 · Terminated

Recall details

Recalling firm

Arrow International Inc

Reason for recall

the catheter peel-away component hub tabs may prematurely detach. One injury reported.

Action taken

Teleflex sent an Urgent Medical Device Recall Notificatin letters dated July 30, 2015 to their affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to: 1. immediately discontinue use and quarantine any products with the catalog and lot number provided in the notice. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507 Attn: Customer Service or email it to recalls@teleflex.com. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of product to Arrow International. 3. Customers were also asked to complete the enclosed Recall Acknowledgment Form if there is no affected product, this will allow for documented receipt of this letter. For questions contact your local sales representative or Customer Service at 1-866-246-6990.

Root cause

Unknown/Undetermined by firm

Status

Terminated

Product code

LJS

Quantity affected

52109

Distribution

US Nationwide Distribution and internationally to Canada

Date initiated

2015-07-30

Date posted

2015-08-25

Date terminated

2018-06-28

Location

Reading, PA

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