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FDA Medical Device Recalls (openFDA)

Arrow International Inc: ARROW PICC powered by ARROW VPS Stylet

Recall number
Z-0690-2018
Recalling firm
Arrow International Inc
Product
ARROW PICC powered by ARROW VPS Stylet
Status
Terminated
Initiated
2017-10-17
Posted
not on file
Terminated
2020-04-21
Reason
The kit may contain an incorrect catheter component. Kits that should contain a 40cm catheter may contain a 55cm catheter.
Root cause
Mixed-up of materials/components
Action
On October 17, 2017 an URGENT Medical Device Recall letter titled "ARROW PICC powered by ARROW VPS Stylet" was mailed to customers instructing them to review inventory and quarantine all affected product which will be returned to the firm. Questions or concerns can be directed to Customer Service at 18662466990.
Quantity
601 eaches
Distribution
AZ, CA, GA, MA, MO, NY, VA
Lot, serial or model codes
CDC 34041 VPS Lot# 23F17A0037 23F17B0035
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

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