FDA Medical Device Recalls (openFDA)
Arrow International Inc: Arrow NextStep Antegrade Chronic Hemodialysis Catheter. Product is used for attaining long-term vascular access for hemodialysis and apheresis.
- Recall number
- Z-2883-2011
- Recalling firm
- Arrow International Inc
- Product
- Arrow NextStep Antegrade Chronic Hemodialysis Catheter. Product is used for attaining long-term vascular access for hemodialysis and apheresis.
- Status
- Terminated
- Initiated
- 2011-06-28
- Posted
- 2011-07-30
- Terminated
- 2012-04-16
- Reason
- Firm has received complaints indicating breakage and/or separation of the stylet within the Arrow(R) NextStep(R) Antegrade Catheters.
- Root cause
- Device Design
- Action
- An "Urgent Medical Device Recall" letter dated June 28, 2011 was issued to consignees. The letter requested that customers check their stock, cease use and distribution, and quarantine all affected product. Consignees were further directed to complete the "Recall Acknowledgement & Stock Status Form", return the form to their sales representative, and return affected product as instructed on the letter. For questions or concerns, call 1-800-233-3187.
- Quantity
- 41
- Distribution
- United States (states of CA, DE, FL, MI, NC, and TN).
- Lot, serial or model codes
- Product Number CS-15192-IXM, Lot Number RV1034909; Product Number CS-15232-IXM, Lot Number RV1034911; Product Number CS-15272-IXM, Lot Number RV1034912; Product Number CS-15312-IXM, Lot Number RV1034913; Product Number CS-15422-IX, Lot Number RV1034914; and Product Number CS-15502-IX, Lot Number RV1034915.
- 510(k) numbers
- ["K102238"]
- PMA numbers
- not on file
- Product code
- MSD
- 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