Pediatric Two-Lumen Central Venous Catheterization Kit with Blue… — Class II medical device recall Z-0053-2020
Terminated recall by Arrow International Inc, reported 2019-10-16, distributed nationwide. Lidstock contains a labeling error. The lidstock shows the catheter cross section of the gauge (GA) values in
| Recall number | Z-0053-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Arrow International Inc, Reading, PA, United States |
| Recall initiated | 2019-05-17 |
| Classified | 2019-10-07 |
| Reported by FDA | 2019-10-16 |
| Terminated | 2020-09-24 |
| Distributed | Nationwide (US) |
| Quantity | 3,143 |
| Reason classes | labeling |
| Lot numbers | 13F18C0374, 13F18D0504, 13F18E0380, 13F18G0180, 13F18G0480, 13F18H0580, 13F18L0507, 13F18L0714, 13F18L0936 |
| Model numbers | AK-25502 |
Product
Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, REF AK-25502 Product Usage; Provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access
Reason for recall
Lidstock contains a labeling error. The lidstock shows the catheter cross section of the gauge (GA) values in a reversed manner.
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-0053-2020. 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.