4FR Single Lumen Pressure Injectable PICC — Class II medical device recall Z-0127-2016
Terminated recall by Arrow International Inc, reported 2015-10-21, distributed nationwide. Labeling inaccuracy in the Instructions for Use (IFU) and Patient Card. The IFU and Patient Card with these pr
| Recall number | Z-0127-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Arrow International Inc, Reading, PA, United States |
| Recall initiated | 2015-09-18 |
| Classified | 2015-10-15 |
| Reported by FDA | 2015-10-21 |
| Terminated | 2020-06-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, NZ |
| Quantity | 31,590 |
| Reason classes | labeling |
| Lot numbers | 23F13H0013, 23F13H0034, 23F13H0692, 23F13H0832, 23F13H0876, 23F13H0994, 23F13J0221, 23F13J0289, 23F13J1010, 23F13J1118, 23F13K0003, 23F13K0097, 23F13K0564, 23F13K0761, 23F13K1064, 23F13K1065, 23F14A1238, 23F14A1240, 23F14A1241, 23F14A1352, 23F14A1419, 23F14B0718, 23F14B0822, 23F14B0844, 23F14B1013, 23F14B1161, 23F14C0575, 23F14C0576, 23F14C0598, 23F14C0640, 23F14C0643, 23F14C1096, 23F14D0217, 23F14D0713, 23F14D1125, 23F14E0173, 23F14E0187, 23F14E0655, 23F14E0751, 23F14E1093 and 229 more |
Product
4FR Single Lumen Pressure Injectable PICC; intravascular therapeutic catheter, for long-term use greater than 30 days.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0127-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.