Device 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
Z-0023-2015
Product summary
- Firm
- Biomedix, Inc.
- Event
- Event 69249
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,928
- Official record key
device-enforcement:Z-0023-2015
Official wording
Reason: 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.
Code information: Model/Product Number: B30-102 Lot #416130 Exp. 12/2016
Distribution pattern: US Distribution including the states of OH, NC, and TX
Derived failure modes
-
Unknown
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.