FDA Medical Device Recalls (openFDA)
Arrow International Inc: Arrow CVC 2 Lumen, Pediatric Two-Lumen Central Venous Cauterization Set with Blue FlexTip Catheter, 4 Fr 2 Lumen 5cm, Reference # CS-12402 The Arrow CVC is intended to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access, including, but not limited to the following: " Lack of usable peripheral IV sites " Central venous pressure monitoring " Total parenteral nutrition (TPN) " Infusions of fluids, medications, or chemotherapy " Frequent blood sampling or receiving blood transfusions/blood products
- Recall number
- Z-0723-2019
- Recalling firm
- Arrow International Inc
- Product
- Arrow CVC 2 Lumen, Pediatric Two-Lumen Central Venous Cauterization Set with Blue FlexTip Catheter, 4 Fr 2 Lumen 5cm, Reference # CS-12402 The Arrow CVC is intended to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access, including, but not limited to the following: " Lack of usable peripheral IV sites " Central venous pressure monitoring " Total parenteral nutrition (TPN) " Infusions of fluids, medications, or chemotherapy " Frequent blood sampling or receiving blood transfusions/blood products
- Status
- Terminated
- Initiated
- 2018-11-14
- Posted
- not on file
- Terminated
- 2020-06-04
- Reason
- The lidstock states the incorrect priming volume and flow rates.
- Root cause
- Error in labeling
- Action
- The firm, Teleflex, sent an "Urgent Medical Device Notification" letter dated 11/13/2018 to its customers on 11/14/2018. The letter described the product, problem and action to be taken. The customers were instructed to do the following: 1. Place a copy of this notification with each unit of affected product currently in your inventory. 2. Using the provided customer letter template and acknowledgement form, communicate this notification to any of your customer who have received product included within the scope of this notification. 3. Have each of your customers who received the affected product return a completed acknowledgement form to you. 4. Once you have finished collecting and consolidating all of the acknowledgement forms from your customers and placing a copy of this notification with each unit of affected product in your inventory, please completed the enclosed Distributor 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 completion of this field action. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-396-2111.
- Quantity
- 15 in the US
- Distribution
- Worldwide distribution: US (nationwide) distribution to state of: FL and to countries of: Argentina, Canada, Chile, Columbia, Costa Rica, Dominican Republic, Ecuador, and Peru.
- Lot, serial or model codes
- Lots 14F18F0336 & 14F18E0121
- 510(k) numbers
- ["K862056"]
- PMA numbers
- not on file
- Product code
- DQY
- 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