FDA Medical Device Recalls (openFDA)
Arrow International Inc: Vascular catheter introduction kit The PICC is indicated for short or long term peripheral access to the central Venous system for intravenous therapy, blood sampling, infusion and power injection of contrast media.
- Recall number
- Z-1228-2017
- Recalling firm
- Arrow International Inc
- Product
- Vascular catheter introduction kit The PICC is indicated for short or long term peripheral access to the central Venous system for intravenous therapy, blood sampling, infusion and power injection of contrast media.
- Status
- Terminated
- Initiated
- 2017-01-11
- Posted
- not on file
- Terminated
- 2018-09-06
- Reason
- There have been complaints for peel away sheaths flaring
- Root cause
- Device Design
- Action
- Arrow International mailed an Urgent Medical Device Advisory Notification letter to affected customers on 01/13/2017 to inform them of the issue. Customers with questions were instructed to contact their local sales representative or Customer Service at 1-866-246-6990.
- Quantity
- 215,703 units
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Material # ASK-01663-MST, ASK-04001-DU4, ASK-04001-DU5, PI-01351-LS, PI-01351-LS5, PI-01351-SS, PI-01552-LS, PI-01552-LS5, PI-01552-SS, PL-05041, PL-05041, PL-05052, PR-05041, PR-05041, PR-05041-T, PR-05042, ASK-01663-MST, ASK-04001-DU4, ASK-04001-DU5, PI-01351-LS, PI-01351-LS5, PI-01351-SS, PI-01351-SS, PI-01451-LS, PI-01451-LS5, PI-01451-SS, PI-01451-SS, PI-0-1552-LS
- 510(k) numbers
- ["K930129"]
- 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