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Terminated

Regard, Item Number 830054002, CV00625B - OPEN HEART A&B - Custom surgical kit for cardiovascular surgery.

FDA Recall Z-0186-2016 · Posted 2015-10-30

Recalling FirmResource Optimization & Innovation Llc
Recall StatusTerminated
Product CodeLHC
Date Initiated2015-08-25
Date Terminated2017-04-06
Product Quantity77 kits

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.

Firm Action

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.

Root Cause

Packaging

Distribution Pattern

Distributed in Texas and Louisiana.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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