Z-0023-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 15, 2014
- Initiation Date
- August 14, 2014
- Termination Date
- November 13, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,928
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
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.
Distribution Pattern
US Distribution including the states of OH, NC, and TX
Code Information
Model/Product Number: B30-102 Lot #416130 Exp. 12/2016