Medium RiskFDA Device

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

Agency Publication Date: October 30, 2015

Affected Products

Product: Regard, Item Number 830019, CV0214H -Custom surgical kit for cardiovascular surgery.

23076, 25396, 26210, and 27186

Product: Regard, Item Number 830045, CV0443D - CV BUNDLE - Custom surgical kit for cardiovascular surgery.

19215, 19570, 20849, 22557, 23871, 25469, and 27185

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

24641

Product: Regard, Item Number 830054001, CV00625A - OPEN HEART A&B - Custom surgical kit for cardiovascular surgery.

22404, 23406, 23642, and 24032

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

19532, 27389, 24399, and 24478

Product: Regard, Item Number 830500003, Sterile, CV0578C - CV PACK - Custom surgical kit for surgery.

26550

Product: Regard, Item Number 800301001, Sterile, CV0708A - OPEN HEART- Custom surgical kit for cardiovascular surgery.

19345

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

24634

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 72052

Status: Resolved

Manufacturer: Resource Optimization & Innovation Llc

Manufactured In: United States

Units Affected: 8 products (84 kits; 80 kits; 77 kits; 153 kits; 57 kits; 17 kits; 28 kits; 10 kits)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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