FDA Recall Terminated

Arrow International, Inc. PICC Kits and VPS Access Kits with Touhy Borst Component Catheter, Intravascular, Therapeutic, Ultrasound, Long Term Greater than 30 Days

Recall: Z-2489-2015 · Initiated July 30, 2015

Recall

Recall Number: Z-2489-2015
Event Number: 71855
Firm: Arrow International Inc
FEI Number: 3015859709
Product Code: OBJ
Status: Terminated
Root Cause: Under Investigation by firm
Initiated: July 30, 2015
Posted: August 31, 2015
Terminated: February 26, 2018
Address: 2400 Bernville Rd, Reading, PA, 19605-9607

Description

Reason

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

Action

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 [email protected]. 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 [email protected]. 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.

Distribution

Worldwide Distribution - US nationwide and Internationally to Canada.

Quantity

92902