Biomedix SELEC-3 I — Class II medical device recall Z-0023-2015
Terminated recall by Biomedix, Inc., reported 2014-10-15, distributed in NC, OH, TX. Customer contacted Biomedix of complaint and returned the failed set along with 86 units of unopened stock (96
| Recall number | Z-0023-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomedix, Inc., Bloomington, IN, United States |
| Recall initiated | 2014-08-14 |
| Classified | 2014-10-06 |
| Reported by FDA | 2014-10-15 |
| Terminated | 2014-11-13 |
| Distributed | NC, OH, TX |
| Quantity | 2,928 |
| Lot numbers | 416130 |
| Expiration dates | 2016-12 |
Product
Biomedix SELEC-3 I.V. Administration Set. Individually sealed into a Tyvek¿ and LDPE/PET pouch. Secondary packaging includes 48 pouched units per box/case. STERILE
Reason for recall
Customer contacted Biomedix of complaint and returned the failed set along with 86 units of unopened stock (96 units originally shipped). Biomedix performed extensive investigation and found insufficient application of glue. Recall was initiated due to the rate of the failure.
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-0023-2015. 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.