Recall Z-1057-2022— SIMPLIVIA HEALTHCARE LTD.

Name: FDA recall Z-1057-2022
Creator: U.S. Food and Drug Administration
Published: 2022-03-08

Class II · Ongoing

Class II FDA medical device recall by SIMPLIVIA HEALTHCARE LTD., initiated 2022-03-08. It names one FDA 510(k) clearance: K192866. Product: OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143. Reason: Disconnection of the OnGuard2 Bag Adaptor SP from infusion bags which may result in spillage of hazardous medications..

Recalling firm: SIMPLIVIA HEALTHCARE LTD.
Classification: Class II
Status: Ongoing
Initiated: 2022-03-08
Firm location: Kiryat Shmona, N/A, Israel

510(k) clearances named in this recall

1 on FDA's record

K192866 — Chemfort CSTDSimplivia Healthcare , Ltd.·cleared 2020-05-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143

Reason for recall

Disconnection of the OnGuard2 Bag Adaptor SP from infusion bags which may result in spillage of hazardous medications.

Data sourced from openFDA. This site is unofficial and independent of the FDA.