—#139793

Product

Regard, Item Number 830565001, CV0654A - PEDIATRIC HEART - Custom surgical kit for cardiovascular surgery.

FDA product code: LHC — Warmer, Irrigation Solution
Device class: Class 1
Medical specialty: Physical Medicine
510(k) numbers: K142080
Affected lot / code info: 19532, 27389, 24399, and 24478

Why it was recalled

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

Root cause (FDA determination)

Packaging

Action the firm took

On August 25, 2015, the recalling firm sent an email to their direct customers informing them of the recall. The email instructed their customers to examine their inventory and determine whether they had any of the affected devices. The recalling firm attached the recall notice they received from their supplier. On September 4, 2015, the recalling firm sent a second email clarifying that they were instructing their customer to discard the supplier component . The notice also asked the customer to respond with how many affected devices they had in their inventory at the time they received the notice.

Recalling firm

Firm: Resource Optimization & Innovation Llc
Address: 2909 N Neergard Ave, Springfield, Missouri 65803

Distribution

Distribution pattern: Distributed in Texas and Louisiana.

Timeline

Recall initiated: 2015-08-25
Posted by FDA: 2015-10-30
Terminated: 2017-04-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #139793. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.