Recalls / —
—#164015
Product
VPS TipTracker Stylet Accessory; Product codes: RHY-177-TTSAP
- FDA product code
- LJS — Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- Device class
- Class 2
- Medical specialty
- General Hospital
- 510(k) numbers
- K160925
- Affected lot / code info
- Lot Numbers: 13F17A0119 13F17D0019 13F17D0130 13F17D0186 13F17D0278 13F17E0113 13F17F0193 13F17F0480 13F17G0074 13F17G0329 13F17G0506 13F17H0536 13F17J0208 13F17K0438
Why it was recalled
Product sterility may be compromised due to unsealed packaging.
Root cause (FDA determination)
Under Investigation by firm
Action the firm took
On April 11, 2018 Arrow International mailed Urgent Medical Device Recall notifications to affected customers. Customers were instructed to take the following actions: 1. If you have affected stock, immediately discontinue use and quarantine any products with the product codes and lot numbers listed above, so that the affected products can be returned to Arrow. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email 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 products 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 to recalls@teleflex.com. This will allow us to document your receipt of this letter. Customers with questions may contact your local sales representative or Customer Service at (866)246-6990.
Recalling firm
- Firm
- Arrow International Inc
- Address
- 2400 Bernville Rd, Reading, Pennsylvania 19605-9607
Distribution
- Distribution pattern
- US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM
Timeline
- Recall initiated
- 2018-04-11
- Terminated
- 2020-05-15
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #164015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.