FDA Medical Device Recalls (openFDA)
Arrow International Inc: Radial Artery Catheterization Kit with Sharps Safety Features Permits access to the peripheral arterial circulation. The safety feature is intended to help minimize the risk of sharps injuries when using the device.
- Recall number
- Z-2741-2016
- Recalling firm
- Arrow International Inc
- Product
- Radial Artery Catheterization Kit with Sharps Safety Features Permits access to the peripheral arterial circulation. The safety feature is intended to help minimize the risk of sharps injuries when using the device.
- Status
- Terminated
- Initiated
- 2016-08-08
- Posted
- 2016-09-07
- Terminated
- 2017-08-22
- Reason
- Shipping carton labeling error.
- Root cause
- Process control
- Action
- Teleflex sent an Urgent Medical Device Recall Notification letter dated August 23, 2016, via FED-Ex 2 Day Air. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use and quarantine all affected products. Instructions for the products return were provided in the firm's recall notification letter. Customers were asked to complete the enclosed Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email it to recalls@teleflex.com. Customers with questions were instructed to call 1-866-246-6990.
- Quantity
- 690 kits
- Distribution
- Nationwide Distribution to OH, IN, TN, NC, and KY.
- Lot, serial or model codes
- Device Listing # D025180
- 510(k) numbers
- ["K810675"]
- PMA numbers
- not on file
- Product code
- DQX
- 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