FDA Device recall Z-0127-2016
4FR Single Lumen Pressure Injectable PICC
- FDA Device
- Class II
- terminated
- Published 2015-10-21
On 2015-10-21 the FDA classified a Class II recall of 4FR Single Lumen Pressure Injectable PICC by Arrow International, citing labeling inaccuracy in the Instructions for Use (IFU) and Patient Card. The IFU and Patient Card with these products state the PICC can withstand up to ten (10) pressure injection….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0127-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-09-18 |
| Published | 2015-10-21 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Arrow International |
| Distribution | US |
Product
4FR Single Lumen Pressure Injectable PICC; intravascular therapeutic catheter, for long-term use greater than 30 days.
Reason
Labeling inaccuracy in the Instructions for Use (IFU) and Patient Card. The IFU and Patient Card with these products state the PICC can withstand up to ten (10) pressure injections, however, the PICC has only been tested to withstand five (5) pressure injections.
Identifiers
| code_info | Material Numbers: ASK-05041-CHC2 ASK-05041-LM4 ASK-05041-QV ASK-05541-MS3 CA-05041-HP CA-05041-HPX CDC-04041-HPK…Material Numbers: ASK-05041-CHC2 ASK-05041-LM4 ASK-05041-QV ASK-05541-MS3 CA-05041-HP CA-05041-HPX CDC-04041-HPK1A CH-04041-HMA EU-04041-HP EU-05041-HPMSB EU-05541-HP EU-05541-HPMSB EU-24041-HP EU-24041-HPMSB EU-24041-IR EU-25041-HP EU-25041-HPMSB EU-25041-IR EU-25541-HP EU-25541-HPMSB EU-25541-IR FR-04041 FR-04041-CF FR-05041 FR-05041-CF PR-04041-HPX PR-05041-HP PR-05541-HPX UK-04041-RDE1 UK-04041-THT UK-05041-HPMIN UK-05041-MSB UK-05041-RDE1 UK-05041-THT with Batch Nos. 23F15E0620 23F15A0584 23F14H0964 23F14F1422 23F13J0289 23F13H0832 23F15C2435 23F14L0090 23F14H0848 23F14F0370 23F14A1352 23F13K0761 23F14H0193 23F15C1236 23F14M0484 23F14L0810 23F14K1361 23F14J0415 23F14E1093 23F14B0844 23F15D0881 23F14L0187 23F15F0752 23F15A1857 23F15D0830 23F14H1112 23F14F1497 23F14C1096 23F14C0640 23F14A1238 23F14A1419 23F14L1144 23F14J1513 23F15D0832 23F15F0147 23F15C0303 23F14J0221 23F14F1504 23F14C0643 23F13K0097 23F13H0 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0127-2016%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.