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FDA Medical Device Recalls (openFDA)

Arrow International Inc: Arrowg+ard Blue Advance JACC Product Code: JRT 43552 HPHNM

Recall number
Z-1817-2019
Recalling firm
Arrow International Inc
Product
Arrowg+ard Blue Advance JACC Product Code: JRT 43552 HPHNM
Status
Terminated
Initiated
2019-04-23
Posted
not on file
Terminated
2021-01-13
Reason
Lidstock states the incorrect expiration date for the product
Root cause
Process control
Action
Arrow International initiated recall by letter dated April 23,2019 described the problem, health risk and action to take: If you have affected stock in inventory, immediately discontinue use and quarantine the products. 2. Complete the enclosed Acknowledgement Form indicating whether you do or do not have stock and fax it to 1-855-419-8507 or email to recalls@teleflex.com. A customer service representative will contact you with a Return Goods Authorization (RGA) number and provide instructions for the return of products. Distributors requested to subrecall. Questions, contact your local sales representative or Customer Service at 1-866-396-2111.
Quantity
52 units
Distribution
Nationwide Foreign:
Lot, serial or model codes
Batch Code: 13F18H0239
510(k) numbers
["K132133"]
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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