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FDA Medical Device Recalls (openFDA)

Arrow International Inc: Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free A(2) Port, 10 Fr. Introducer Kit Ref Product No. AP-06530

Recall number
Z-0273-2007
Recalling firm
Arrow International Inc
Product
Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free A(2) Port, 10 Fr. Introducer Kit Ref Product No. AP-06530
Status
Terminated
Initiated
2006-09-29
Posted
2006-12-19
Terminated
2007-06-04
Reason
Catheter has separated from the infusion port body.
Root cause
Other
Action
The recall notification was sent out to their US customers on 9/29/2006.
Quantity
210
Distribution
Nationwide. The firm is NOT recalling from international accounts.
Lot, serial or model codes
Product No: AP-06530. Lot Numbers: 11750, 11999, 12059, MF4031397, MF4042081, MF4062934, MF4063103, MF4073794, MF5027702, MF5059738, MF5060177, MF5060656, MF5081903, MF5103211, MF6036473, MF6036909, MF6068938, MS3100148.
510(k) numbers
["K790882","K950212"]
PMA numbers
not on file
Product code
LJT
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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