Recalls / —
—#163862
Product
Radial Artery Catheterization Kit; Product Codes: ASK-04020-AH, ASK-04020-MIHS, ASK-04120-HF1
- FDA product code
- DQX — Wire, Guide, Catheter
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- 510(k) numbers
- K810675
- Affected lot / code info
- Lot Numbers: Product code ASK-04020-AH: 13F17B0102 13F17C0283 13F17F0221 13F17G0480 13F17J0045 13F17L0127 Product code ASK-04020-MIHS: 13F17A0174 13F17F0139 Product code ASK-04120-HF1: 13F17C0360 13F17D0034 13F17E0093 13F17F0468 13F17G0269 13F17J0101 13F17K0311 13F17L0489
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 #163862. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.