Arrow International — Class II medical device recall Z-2489-2015
Terminated recall by Arrow International Inc, reported 2015-09-09, distributed nationwide. saline leakage from unsecured connections between the Touhy Borst adaptor and the hub of the catheter. No inju
| Recall number | Z-2489-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Arrow International Inc, Reading, PA, United States |
| Recall initiated | 2015-07-30 |
| Classified | 2015-08-31 |
| Reported by FDA | 2015-09-09 |
| Terminated | 2018-02-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 92,902 |
| Reason classes | packaging |
| Lot numbers | 19F13H0022, 19F13H0023, 19F13J0011, 19F13J0012, 19F13J0013, 19F13J0014, 19F13J0015, 19F13K0005, 19F13K0006, 19F13K0007, 19F13K0008, 19F13K0009, 19F13K0016, 19F13K0017, 19F13K0018, 19F13K0019, 19F13K0020, 19F13L0007, 19F13L0009, 19F13L0010, 19F13L0011, 19F13L0028, 19F13L0029, 19F13L0030, 19F13L0031, 19F13L0036, 19F13L0037, 19F13L0038, 19F13L0039, 19F13M0006, 19F13M0007, 19F13M0008, 19F13M0009, 19F14B0006, 19F14B0007, 19F14B0008, 19F14B0010, 19F14B0012, 19F14C0003, 19F14D0005 and 209 more |
Product
Arrow International, Inc. PICC Kits and VPS Access Kits with Touhy Borst Component Catheter, Intravascular, Therapeutic, Ultrasound, Long Term Greater than 30 Days
Reason for recall
saline leakage from unsecured connections between the Touhy Borst adaptor and the hub of the catheter. No injuries reported.
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-2489-2015. 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.