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FDA Medical Device Recalls (openFDA)

Arrow International Inc: AGB+ Multi Lumen Central Venous Catheterization Kit; Product Codes: CDC-42703-XP1A and CDC-47702-XP1A; Exp. Dates Feb 2018 - Nov 2018

Recall number
Z-0655-2018
Recalling firm
Arrow International Inc
Product
AGB+ Multi Lumen Central Venous Catheterization Kit; Product Codes: CDC-42703-XP1A and CDC-47702-XP1A; Exp. Dates Feb 2018 - Nov 2018
Status
Terminated
Initiated
2017-10-17
Posted
2018-02-20
Terminated
2020-04-14
Reason
These finished good kits may contain the incorrect Springwire Guide (SWG).
Root cause
Process control
Action
On October 17, 2017 an Urgent Medical Device recall letter from Arrow International was issued to customers requesting that customers review their inventory for product, which should immediately be discontinued and quarantined. The products are then to be returned to the firm. Questions or concerns can be directed to: Customer Service at 18662466990.
Quantity
5,926 total
Distribution
Distribution US Nationwide
Lot, serial or model codes
Lot numbers:  Product Codes CDC-42703-XP1A: 23F16M0507 Product Code CDC-47702-XP1A: 23F17A0533
510(k) numbers
["K071538"]
PMA numbers
not on file
Product code
FOZ
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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