Recall of Pediatric Cardiac Catheterization Trays Due to Glove Splitting
Resource Optimization & Innovation LLC is recalling 27 pediatric cardiac catheterization trays because a light glove component can split, breaking the sterile field.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sterile field breach) where injury has not yet been reported, fitting the 'High' severity criteria for medical devices with potential for harm but no confirmed adverse events.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 27 kits of Regard Pediatric Card Cath trays (Item Number 800555002, Sterile, HT0644B). The recall affects specific lots with expiration dates of August 23, 2018, and October 10, 2018. These products were distributed in the United States to locations in California and Texas.
The recall was initiated because the trays contain a light glove component that can split during application to a light handle. This defect can break the sterile field, which is a critical safety requirement for sterile medical procedures.
Healthcare facilities that have received these specific trays should stop using them and contact the recalling firm for instructions on how to return or dispose of the affected products.
The recalled product
- Product
- Regard, Item Number: 800555002, Sterile, HT0644B - Pediatric Card Cath - Childrens Santa Rosa
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Hazard
- Affected units
- 27
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 (2)
- 037622B Exp Date 2018-08-23
- 038777B Exp Date 2018-10-10
Distribution
Part of a larger recall action
This product is one of 135 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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