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Terminated

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

FDA Recall Z-2489-2015 · Posted 2015-08-31

Recall StatusTerminated
Product CodeOBJ
Date Initiated2015-07-30
Date Terminated2018-02-26
Product Quantity92902

Reason for Recall

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

Firm 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.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide Distribution - US nationwide and Internationally to Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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