FDA Device recall Z-0023-2015
Biomedix SELEC-3 I.V. Administration Set
- FDA Device
- Class II
- terminated
- Published 2014-10-15
On 2014-10-15 the FDA classified a Class II recall of Biomedix SELEC-3 I.V. Administration Set by Biomedix, citing customer contacted Biomedix of complaint and returned the failed set along with 86 units of unopened stock (96 units originally shipped). Biomedix performed extensive investigatio….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0023-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-08-14 |
| Published | 2014-10-15 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Biomedix |
| Distribution | NC, OH, TX |
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
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.
Identifiers
| code_info | Model/Product Number: B30-102 Lot #416130 Exp. 12/2016 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0023-2015%22
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