—#165304

Product

Percutaneous Sheath Introducer Kit for use with 7 - 7.5 Fr. Catheters (8 Fr. 10 cm sheath length .035 inch dia. spring-wire guide), REF ES-09807. The percutaneous sheath introducer permits venous access and catheter introduction to the central circulation.

FDA product code: DYB — Introducer, Catheter
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K780532
Affected lot / code info: Lot/Batch Number: 13F18A0037 Expiration Date/Expected Life: Apr 2019

Why it was recalled

Product contains dry natural rubber latex. Label states Latex Free.

Root cause (FDA determination)

Process control

Action the firm took

On May 23, 2018, Arrow International issued Urgent Medical Device Recall notices and response forms to their customer. Customers are advised to take the following actions: 1. Immediately discontinue distribution and quarantine affected product. 2. Using the provided customer letter and Recall Acknowledgement Form templates, customers who have further distributed product should contact those individuals. 3. To return affected products from your inventory, complete and return the Recall Acknowledgement Form via to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. 4. If you and your customers have no affected stock, please complete and return the Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. 5. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-396-2111.

Recalling firm

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

Distribution

Distribution pattern: Puerto Rico

Timeline

Recall initiated: 2018-05-23
Terminated: 2020-05-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #165304. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.