FDA Medical Device Recalls (openFDA)
Arrow International Inc: 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.
- Recall number
- Z-2576-2018
- Recalling firm
- Arrow International Inc
- 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.
- Status
- Terminated
- Initiated
- 2018-05-23
- Posted
- not on file
- Terminated
- 2020-05-20
- Reason
- Product contains dry natural rubber latex. Label states Latex Free.
- Root cause
- Process control
- Action
- 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.
- Quantity
- 60 units
- Distribution
- Puerto Rico
- Lot, serial or model codes
- Lot/Batch Number: 13F18A0037 Expiration Date/Expected Life: Apr 2019
- 510(k) numbers
- ["K780532"]
- PMA numbers
- not on file
- Product code
- DYB
- Firm FEI
- 3015859709
- Firm city
- Reading
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28