FDA Medical Device Recalls (openFDA)
Arrow International Inc: The CG+ Arrow PIC Catheters permit venous access to the central circulation through a peripheral vein.
- Recall number
- Z-1705-2017
- Recalling firm
- Arrow International Inc
- Product
- The CG+ Arrow PIC Catheters permit venous access to the central circulation through a peripheral vein.
- Status
- Terminated
- Initiated
- 2017-03-03
- Posted
- 2017-03-08
- Terminated
- 2018-02-27
- Reason
- Arrow International, Inc. notified its customers who received the affected Antimicrobial/Antithrombogenic PICC Kits, that the kits were being recalled due to a labeling error. The lidstock on some of the kits reads CDC-45541-HPK1A, while the banner card on the side of the kit reads CDC-45052-HPK1A. Other kits may list CDC-45052-HPK1A on the lidstock and CDC-45541-HPK1A on the banner card. The affected lot numbers are 23F16C0851, 23F16A0727, and 23F16C0844.
- Root cause
- Under Investigation by firm
- Action
- Arrow International mailed an Urgent Medical Device Recall Notification letter to affected customers on March 7, 2017, to inform them of the issue. The notification informs customers to discontinue use and quarantine any products identified with the specific lot numbers. Customers are asked to complete the enclosed Recall Acknowledgement Form for product return. For further questions, please call (866) 246-6990.
- Quantity
- 1,351 catheters
- Distribution
- US Distribution
- Lot, serial or model codes
- Device Listing Number: D149129 Lot Numbers: 23F16C0851, 23F16A0727 and 23F16C0844
- 510(k) numbers
- ["K112896"]
- PMA numbers
- not on file
- Product code
- LJS
- 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