—#164012

Product

Arrow PICC with Chlorag+ard Technology; Product codes: PR-44041-BAS, PR-44052-BAS, PR-44063-BAS, PR-45041-BAS, PR-45052-BAS, PR-45063-BAS, PR-45541-BAS,PR-45541-HPHNL, PR-45541-HPHNM, PR-45552-BAS, PR-45552-HPHNL,PR-45552-HPHNM, PR-45563-BAS, PR-45563-HPHNL, PR-45563-HPHNM

FDA product code: LJS — Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K130876
Affected lot / code info: Lot Numbers: Product code: PR-44041-BAS: 13F17F0101 PR-44052-BAS: 13F17F0103 13F17K0128 PR-44063-BAS: 13F17F0104 13F17K0129 PR-45041-BAS: 13F17F0105 13F17K0241 PR-45052-BAS: 13F17F0106 13F17K0236 PR-45063-BAS: 13F17J0203 13F17K0471 PR-45541-BAS: 13F17F0107 PR-45541-HPHNL: 13F17A0165 13F17D0327 13F17G0008 13F17H0416 13F17H0572 13F17K0238 13F17L0049 PR-45541-HPHNM: 13F17B0174 13F17C0188 13F17E0738 13F17G0006 PR-45552-BAS: 13F17F0108 13F17K0237 PR-45552-HPHNL: 13F17C0467 13F17E0017 13F17E0758 13F17F0523 PR-45552-HPHNM: 13F17B0178 13F17C0469 13F17E0120 13F17G0412 13F17H0393 13F17J0172 13F17L0335 PR-45563-BAS: 13F17F0109 PR-45563-HPHNL: 13F17C0354 13F17D0341 13F17J0402 PR-45563-HPHNM: 13F17L0688

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 #164012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.