FDA Medical Device Recalls (openFDA)
Arrow International Inc: ARROW PICC powered by ARROW VPS Stylet, Product Codes: CDC-35052-VPS and CDC-35041-VPS. Peripherally Inserted Central Catheter
- Recall number
- Z-0601-2018
- Recalling firm
- Arrow International Inc
- Product
- ARROW PICC powered by ARROW VPS Stylet, Product Codes: CDC-35052-VPS and CDC-35041-VPS. Peripherally Inserted Central Catheter
- Status
- Terminated
- Initiated
- 2017-07-25
- Posted
- not on file
- Terminated
- 2018-08-29
- Reason
- Finished good kits may contain incorrect components. Kits that should contain a 5 FR 2 lumen catheter may contain a 4 FR single lumen catheter and kits that should contain a 4 FR single lumen catheter may contain a 5 FR 2 lumen catheter. This may cause a delay in treatment while a replacement catheter is obtained.
- Root cause
- Packaging process control
- Action
- Arrow International notified all U.S. consignees with letter sent on July 25, 2017, via FedEx 2-day. second notification August 22, 2017, third notification November 28, 2017.
- Quantity
- 2691 total
- Distribution
- US nationwide distribution.
- Lot, serial or model codes
- Lot/Batch Numbers: 23F17A0038, 23F17A0040, 23F16M0059.
- 510(k) numbers
- ["K121941"]
- 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