The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0023-2015·Announced 2014-10-15

Biomedix SELEC-3 I.V. Administration Set Recalled Due to Adhesive Failure

Biomedix is recalling SELEC-3 I.V. Administration Sets because insufficient glue application caused the sets to fail.

The agency’s classification

FDA (Devices): Class II

Class II is 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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a structural defect (insufficient glue) that caused failure. While no injuries are reported, the risk of harm from a failed IV administration set justifies a High severity rating under the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Biomedix, Inc. is recalling 2,928 units of SELEC-3 I.V. Administration Sets. The product is individually sealed in Tyvek and LDPE/PET pouches, with 48 units per box. The specific lot number is 416130, with an expiration date of 12/2016.

The recall was initiated after a customer reported a failure and returned the failed set along with 86 units of unopened stock. Biomedix's investigation determined that the failure was caused by insufficient application of glue. The company initiated the recall due to the rate of the failure.

The affected units were distributed in the United States, including the states of Ohio, North Carolina, and Texas. Consumers and healthcare facilities should stop using the affected product and contact Biomedix for instructions on return or replacement.

The recalled product

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
Manufacturer
Biomedix, Inc.
Category
Medical Device — IV Administration Set
Hazard
Affected units
2,928

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Model/Product Number: B30-102 Lot #416130 Exp. 12/2016

Distribution

Distributed in 3 states:

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