SELEC-3 I.V. Set (Biomedix) – Product Failure (2014)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Biomedix, Inc.
Lot Codes / Batch Numbers
Model/Product Number: B30-102 Lot #416130 Exp. 12/2016
Products Sold
Model/Product Number: B30-102 Lot #416130 Exp. 12/2016
Biomedix, Inc. is recalling Biomedix SELEC-3 I.V. Administration Set. Individually sealed into a Tyvek¿ and LDPE/PET pouch. Se due to Customer contacted Biomedix of complaint and returned the failed set along with 86 units of unopened stock (96 units originally shipped). Biomedix pe. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
NC, OH, TX
Page updated: Jan 10, 2026