PICC Kits with Peel-Away Sheath Component — Class II medical device recall Z-2462-2015
Terminated recall by Arrow International Inc, reported 2015-09-02, distributed nationwide. the catheter peel-away component hub tabs may prematurely detach. One injury reported.
| Recall number | Z-2462-2015 |
|---|---|
| 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 | 2015-08-25 |
| Reported by FDA | 2015-09-02 |
| Terminated | 2018-06-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 52,109 |
| Reason classes | device malfunction |
| Lot numbers | 23F14A1419, 23F14A1779, 23F14B0844, 23F14B0935, 23F14B1013, 23F14B1128, 23F14B1144, 23F14B1232, 23F14C0059, 23F14C0473, 23F14C0575, 23F14C0576, 23F14C0598, 23F14C0640, 23F14C0643, 23F14C1096, 23F14D0042, 23F14D0217, 23F14D0281, 23F14D0282, 23F14D0285, 23F14D0308, 23F14D0456, 23F14D0713, 23F14D0724, 23F14D1125, 23F14E0406, 23F14E0791, 23F14E1093, 23F14E1124, 23F14E1213, 23F14E1215, 23F14E1261, 23F14E1262, 23F14E1325, 23F14E1373, 23F14E1469, 23F14E1493, 23F14F0106, 23F14F0115 and 169 more |
Product
PICC Kits with Peel-Away Sheath Component; catheter, intravascular, therapeutic, ultrasound Product Usage: catheter, intravascular, therapeutic, ultrasound
Reason for recall
the catheter peel-away component hub tabs may prematurely detach. One injury 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-2462-2015. 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.