—#162062

Product

Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Product Usage: The Arrow CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluids, medications, or chemotherapy infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values frequent blood sampling or blood/blood component infusions infusion of incompatible medications central venous pressure monitoring lack of usable peripheral IV sites replacement of multiple peripheral sites for IV access injection of contrast media When used for pressure injection of contrast media, do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with pressure injectable CVC may not exceed 400 PSI. Catheter and Sharps Safety Features

FDA product code: FOZ — Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K071538
Affected lot / code info: ASK-45703-PRJ 13F16M0019 13F17B0343 13F17D0113 13F17G0059 13F17H0095

Why it was recalled

Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.

Root cause (FDA determination)

Error in labeling

Action the firm took

On November 29, 2017 an Urgent Medical Device Correction notice was issued to customers stating the following: Our records indicate that you have received products that are subject to this action. We are now notifying our distributors to take the following actions: 1. Immediately discontinue distribution and quarantine any products with the product codes and lot numbers listed above. 2. Inspect affected products within your control to identify whether they have the sticker with the lot number, expiration date, and UDI information. Products missing this sticker should be returned to Arrow International so they are not distributed to health care providers in error. Products which are properly labeled should not be returned. 3. Using the provided Customer Letter and Acknowledgement Form templates, communicate this correction to any of your customers who have received products included within the scope of the correction. Customers should return mislabeled products. Products that are properly labeled should not be returned. 4. If any of your customers have mislabeled products to return, have them return the affected products to you, together with a completed Acknowledgement Form, for consolidation and return to Arrow International. In the event that an alternative approach is needed, contact Customer Service for more information at 1-866-246-6990. 5. To return products to Arrow International, complete the enclosed Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email it 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 product to Arrow International. 6. If you and your customers have no affected stock or if the products in your stock are properly labeled, please complete the enclosed Acknowledgment Form and fax it to 1-855-419

Recalling firm

Firm: Arrow International Inc
Address: 2400 Bernville Rd, Reading, Pennsylvania 19605-9607

Distribution

Distribution pattern: US in the states of OH, FL, SC, TX, KY, NJ, MI

Timeline

Recall initiated: 2017-11-27
Terminated: 2020-09-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #162062. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.