Multi-Lumen PI CVC Kit and PSI Kit: 3-L 7 FR X 8 product code:… — Class II medical device recall Z-1005-2015
Terminated recall by Arrow International Inc, reported 2015-01-28, distributed in KY. the Instructions for Use (IFU) were inadvertently removed from the kit.
| Recall number | Z-1005-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Arrow International Inc, Reading, PA, United States |
| Recall initiated | 2014-12-16 |
| Classified | 2015-01-21 |
| Reported by FDA | 2015-01-28 |
| Terminated | 2015-08-10 |
| Distributed | KY |
| Quantity | 420 |
| Lot numbers | 23F13L0166, 23F14C1014, 8.5FR |
| Expiration dates | 2015-07-31, 2015-08-31 |
Product
Multi-Lumen PI CVC Kit and PSI Kit: 3-L 7 FR X 8 product code: ASK-45703-POSU lot #23F13L0166, exp. 31-Jul-2015: Product Usage: Multi-Lumen PI CVC Kit: An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patients vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials. PSI Kit: A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.
Reason for recall
the Instructions for Use (IFU) were inadvertently removed from the kit.
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-1005-2015. 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.