Z-0023-2015Class II

Biomedix SELEC-3 I.V. Administration Set. Individually sealed into a Tyvek and LDPE/PET pouch. Secondary...

Name: Z-0023-2015 Biomedix SELEC-3 I.V. Administration Set. Individually sealed into a Tyvek and LDPE/PET pouch. Secondary...
Creator: Biomedix, Inc.
Published: 2014-08-14
License: https://open.fda.gov/license/

Biomedix Wai / initiated 2014-08-14 / Terminated / root cause: manufacturing process

FDA source

Biomedix, Inc. began a recall of 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... on 2014-08-14. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0023-2015
Classification: Class II
Status: Terminated
Initiated: 2014-08-14
Posted: 2014-10-06
Terminated: 2014-11-13
Recalling firm: Biomedix Wai
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
Product code: FPA Set, Administration, Intravascular
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 2,928
Distribution: US Distribution including the states of OH, NC, and TX
Product codes and lots: Model/Product Number: B30-102 Lot #416130 Exp. 12/2016

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0023-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0023-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-15	2014-10-06

Product code FPA

K142097Class IISelec-3 I.v.administration SetBiomedix, Inc. / cleared 2014-08-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)