Aguja de Aspiracion con Profundidad Ajustable Tipo I 16ga x 5 cm-… — Class II medical device recall Z-0818-2019
Terminated recall by Angiotech (Manan Medical Products, Inc.), reported 2019-02-13, distributed nationwide. Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of t
| Recall number | Z-0818-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Angiotech (Manan Medical Products, Inc.), Wheeling, IL, United States |
| Recall initiated | 2018-12-18 |
| Classified | 2019-02-07 |
| Reported by FDA | 2019-02-13 |
| Terminated | 2020-08-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | KR, MX |
| Quantity | 1,404 units |
| Reason classes | sterility, packaging |
| Lot numbers | LK2L |
| Model numbers | UCIN-16-5 |
Product
Aguja de Aspiracion con Profundidad Ajustable Tipo I 16ga x 5 cm- Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.
Reason for recall
Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line
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-0818-2019. 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.