Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall 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

U.S. FDA — Device Enforcement · United States · 2014-08-14 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0023-2015
Date of alert
2014-08-14
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Biomedix, Inc.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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