FDA Recalls Pediatric Heart Surgical Kits Due to Sterility Concerns
Resource Optimization & Innovation LLC is recalling 57 pediatric heart surgical kits because compromised package integrity may affect sterility assurance.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states the agency classification is Class II. According to the severity rubric, an FDA Class II recall must be scored as 4 (Severe) regardless of other factors.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling 57 custom surgical kits intended for pediatric cardiovascular surgery. The kits, identified by Item Number 830565001 and CV0654A, were distributed in Texas and Louisiana. The recall is due to a component within the kits, specifically ORS fluid warming and slush drapes, which was previously recalled because compromised package integrity potentially affects sterility assurance.
The affected lots are identified by codes 19532, 27389, 24399, and 24478. The recalling firm is Resource Optimization & Innovation LLC. The FDA has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Healthcare facilities and consumers who have these specific kits should stop using them immediately. Users should contact the manufacturer or their supplier for instructions on how to return the product or obtain a replacement. This recall is limited to the specific item numbers and lot codes listed above.
The recalled product
- Product
- Regard, Item Number 830565001, CV0654A - PEDIATRIC HEART - Custom surgical kit for cardiovascular surgery.
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Affected units
- 57
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- 19532
- 27389
- 24399
- and 24478
Distribution
Part of a larger recall action
This product is one of 8 recalled by Resource Optimization & Innovation Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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