Biomedix SELEC-3 I.V. Administration Set. Individually… recallZ-0023-2015 · Biomedix, Inc. · initiated Aug 14, 2014
Class II Terminated All recalls posted in October 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Biomedix, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process control
What the company is doing
Biomedix sent an PRODUCT RECALL NOTIFICATION letter dated August 14, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please contact us with the quantity remaining in inventory or available to be returned to our facility. All units returned to Biomedix will be replaced with the same SELEC-3 item or a similar design at no charge. Please call (1-800-627-2765 ) for further questions.
Recall details
- Recall number
- Z-0023-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Aug 14, 2014
- Posted by the FDA
- Oct 6, 2014
- Recalling firm
- Biomedix, Inc.
- Quantity
- 2,928
- Product code
- FPA
- FDA submissions
- K142097
- Distribution
- US Distribution including the states of OH, NC, and TX
Product description
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
Code information (models, lots, serial numbers)
Model/Product Number: B30-102 Lot #416130 Exp. 12/2016
Other devices under the same FDA submission
1 device cleared under K142097 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Biomedix B31 SELEC-3+NIS+LAS IV ADM. SET B31-102Biomedix-Inc · Set, I.V. Fluid Transfer1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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