Recall of Custom Procedure Trays with Defective Light Gloves
Resource Optimization & Innovation LLC is recalling 158 custom procedure trays because the included light gloves 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.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 158 custom procedure trays, specifically Item Number 800551003, Sterile, GS0640C - Lap Chole - Medical Center Santa Rosa. The affected units were distributed in the United States to locations in California and Texas. The recall involves two specific lot codes: 038257C with an expiration date of September 16, 2018, and 040017C with an expiration date of December 6, 2018.
The recall was initiated because the trays contain a component, a light glove, that has been recalled by the manufacturer. This component can split during application to a light handle. If the glove splits, it breaks the sterile field, which is a critical requirement for surgical procedures.
Healthcare facilities and consumers who have these specific procedure trays should stop using them immediately. Users should check their inventory for the item number 800551003 and the lot codes 038257C or 040017C. Affected units should be quarantined and returned to the recalling firm or disposed of according to local regulations.
The recalled product
- Product
- Regard, Item Number: 800551003, Sterile, GS0640C - Lap Chole - Medical Center Santa Rosa
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Hazard
- Affected units
- 158
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)
- 038257C Exp Date 2018-09-16
- 040017C Exp Date 2018-12-06
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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