FDA Recalls 170 Custom Procedure Trays Due to Sterile Field Breach Risk
Resource Optimization & Innovation LLC is recalling 170 custom procedure 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 is classified as FDA Class II. The hazard involves breaking the sterile field, which poses a risk of harm (infection) but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 170 units of the Regard, Item Number: 800546001 Sterile, GS0635A - Abdominal - Medical Center Santa Rosa custom procedure trays. The recall is being conducted by the U.S. Food and Drug Administration under recall number Z-1604-2017.
The recall is due to a defect in a light glove component included in the trays. The manufacturer has determined that this component can split during application to a light handle, which breaks the sterile field. The affected lots have expiration dates of January 14, 2018, and March 25, 2018.
The product was distributed in the United States to locations in California and Texas. Healthcare facilities and consumers who possess these specific trays should stop using them and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Regard, Item Number: 800546001 Sterile, GS0635A - Abdominal - Medical Center Santa Rosa
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Affected units
- 170
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)
- 030876A Exp Date 2018-01-14
- 032509A Exp Date 2018-03-25
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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