FDA Device recall Z-0182-2018
ArrowADVANTAGE5" Pressure Injectable Peripherally Inserted Central Catheter (PICC) The Pressure Injectable PICC is indicated for short or l…
- FDA Device
- Class II
- terminated
- Published 2017-12-06
On 2017-12-06 the FDA classified a Class II recall of ArrowADVANTAGE5" Pressure Injectable Peripherally Inserted Central Catheter (PICC) The Pressure Injectable PICC is indicated for short or l… by Arrow International, citing there is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0182-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-06-01 |
| Published | 2017-12-06 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Arrow International |
| Distribution | US |
Product
ArrowADVANTAGE5" Pressure Injectable Peripherally Inserted Central Catheter (PICC) The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, power injection of contrast media and allows for central venous pressure monitoring
Reason
There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths.
Identifiers
| code_info | Lot/Batch Number: 23F16L0021 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Other recalls by Arrow International
- Description/REF: PI PICC: 3: 6FR x 55CM w CHG/ DLX-35563-HPKC
FDA Device · Class I · 2026-06-24 · Arrow International - Description/REF: BIOPSY SYSTEM COMPREHENSIVE KIT/ASK-09458-AH, ASK-09458-COC, ASK-09458-EUH, ASK-09458-SD, ASK-09458-VU
FDA Device · Class I · 2026-06-24 · Arrow International - Description/REF: HEMODIALYSIS KIT: 2L 14 FR X 20 CM AGB CDC-25142-X1A
FDA Device · Class I · 2026-06-24 · Arrow International - Description/REF: SAC KIT: 18 GA X 12CM W BIO/SAC-01218-B
FDA Device · Class I · 2026-06-24 · Arrow International - Description/REF: RA CATH KIT: 20 GA X 1-3/4IN/AK-04020-SPC
FDA Device · Class I · 2026-06-24 · Arrow International
All Arrow International recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0182-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.