Recall Z-0191-2016— Resource Optimization & Innovation Llc

Name: FDA recall Z-0191-2016
Creator: U.S. Food and Drug Administration
Published: 2015-08-25

Class II · Terminated

Class II FDA medical device recall by Resource Optimization & Innovation Llc, initiated 2015-08-25, terminated 2017-04-06. It names one FDA 510(k) clearance: K142080. Product: Regard, Item Number 800500002, Sterile, CV0578B - CV PACK- Custom surgical kit for surgery.. Reason: Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance..

Recalling firm: Resource Optimization & Innovation Llc
Classification: Class II
Status: Terminated
Initiated: 2015-08-25
Terminated: 2017-04-06
Firm location: Springfield, MO, United States

510(k) clearances named in this recall

1 on FDA's record

K142080 — NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE /FLUID WARMER DRAPE,SKIRTEDEcolab, Inc.·cleared 2014-08-28

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

Regard, Item Number 800500002, Sterile, CV0578B - CV PACK- Custom surgical kit for surgery.

Reason for recall

Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.

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