FDA Medical Device Recalls (openFDA)
Arrow International Inc: Implantable Vascular Access system -- Infusion Ports with Silicone Rubber Catheter. Latex-Free Low Profile Port. 10 Fr. Introducer Kit Ref Product No. AP-06022
- Recall number
- Z-0280-2007
- Recalling firm
- Arrow International Inc
- Product
- Implantable Vascular Access system -- Infusion Ports with Silicone Rubber Catheter. Latex-Free Low Profile Port. 10 Fr. Introducer Kit Ref Product No. AP-06022
- 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
- 1924
- Distribution
- Nationwide. The firm is NOT recalling from international accounts.
- Lot, serial or model codes
- Product No. AP-06022. Lot Numbers: 12025, 12026, MF2082053, MF2092149, MF2102348, MF2112612, MF2112798, MF2122887, MF3013239, MF3023441, MF3033609, MF3033767, MF3043953, MF3054471, MF3054551, MF3064671, MF3064720, MF3074950, MF3075080, MF3085227, MF3085410, MF3106022, MF3126356, MF3116146, MF4020300, MF4020624, MF4031189, MF4041636, MF4041931, MF4052351, MF4063054, MF4063107, MF4063265, MF4073781, MF4073838, MF4105285, MF4105479, MF4105680, MF4126531, MF4126772, MF4126885, MF5017407, MF5028155, MF5038764, MF5050041, MF5059731, MF5059893, MF5060649, MF5081721, MF5082121, MF5092678. MF5103209, MF5103504, MF5113992, MF5114145, MF5124303, MF6015495, MF6036710, MF6047367, MF6047368, MF6057762, MF6058411, MF6068650, MS3110150, MS4041840.
- 510(k) numbers
- ["K790882","K933316"]
- 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