FDAFDA · Food and drugs·Recall number Z-0023-2015
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
Published October 15, 2014 · Recall initiated: August 14, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Biomedix, Inc.
- Distributor
- US Distribution including the states of OH, NC, and TX
- Lot
- Model/Product Number: B30-102 Lot #416130 Exp. 12/2016
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.