ARROW OnControl Bone Marrow Biopsy System Tray — Class II medical device recall Z-0675-2017
Terminated recall by Teleflex Medical, reported 2016-12-07, distributed nationwide. Sterility: Due to a potential incomplete seal on the outer sterile package.
| Recall number | Z-0675-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teleflex Medical, Research Triangle Park, NC, United States |
| Recall initiated | 2016-11-08 |
| Classified | 2016-11-30 |
| Reported by FDA | 2016-12-07 |
| Terminated | 2019-11-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | BR, CA, EC, GT, MX, PE |
| Quantity | 113,647 units |
| Reason classes | sterility, packaging |
| Lot numbers | 010184, 010256, 010257, 010438, 010439, 010440, 010556, 010557, 010559, 010737, 010738, 010739, 010946, 010947, 010949, 011037, 011046, 011047, 011048, 011052, 011215, 011216, 011217, 011218, 011374, 011380, 011381, 011383, 011384, 011385, 011386, 011675, 011676, 011720, 011945, 011946, 011947, 011948, 012139, 012140 and 75 more |
Product
ARROW OnControl Bone Marrow Biopsy System Tray, Sterile, Rx only, Manufactured for: Teleflex Medical, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients. The Arrow¿ OnControl Bone Marrow Biopsy System is intended for bone marrow core biopsy of the anterior or posterior iliac crest of adult patients
Reason for recall
Sterility: Due to a potential incomplete seal on the outer sterile package.
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-0675-2017. 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.