Arrow International, Inc. PICC Kits and VPS Access Kits with Touhy Borst Component Catheter, Intravascular, Therapeutic,

FDA device recall Z-2489-2015 · posted 2015-08-31 · Terminated

Recall details

Recalling firm

Arrow International Inc

Reason for recall

saline leakage from unsecured connections between the Touhy Borst adaptor and the hub of the catheter. No injuries reported.

Action taken

Arrow International sent an Urgent Medical Device Recall Notification letter dated July 30, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to do the following: If you have affected stock, immediately discontinue use and quarantine any products with the catalog and lot number listed above. 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. This will allow us to document the amount of product you have on hand for return. 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. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email it to recalls@teleflex.com. This will allow us to document your receipt of this letter. Customers with questions were instructed to call their local sales representative or Customer Service at 1-866-246-6990. For questions regarding this recall call 610-378-0131.

Root cause

Under Investigation by firm

Status

Terminated

Product code

OBJ

Quantity affected

92902

Distribution

Worldwide Distribution - US nationwide and Internationally to Canada.

Date initiated

2015-07-30

Date posted

2015-08-31

Date terminated

2018-02-26

Location

Reading, PA

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