FDA Recalls 216 Custom Procedure Trays Due to Glove Splitting Hazard
Resource Optimization & Innovation LLC is recalling 216 custom procedure trays because a light glove component can split, breaking the sterile field.
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 identifies this as an FDA Class II recall. Per the rubric, FDA Class II recalls are classified as Severe (Score 4), particularly when involving structural defects that compromise sterile fields in medical devices.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for 216 custom procedure trays manufactured by Resource Optimization & Innovation LLC. The affected product is identified as 'Regard, Item Number: 800553001, Sterile, OR0642A - Total Knee - Medical Center Santa Rosa.'
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 in medical procedures. The agency classifies this as a Class II recall, indicating that use of the product could cause temporary or medically reversible health problems.
The affected units were distributed in the United States to locations in Louisiana and Texas. Specific lot codes and expiration dates associated with the recall include 030564A (Exp 2017-11-30), 031034A (Exp 2017-11-30), 0318321A (Exp 2018-01-30), and 033317A (Exp 2018-03-30). Healthcare facilities should stop using these trays and contact the manufacturer for instructions on return or disposal.
The recalled product
- Product
- Regard, Item Number: 800553001, Sterile, OR0642A - Total Knee - Medical Center Santa Rosa
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Affected units
- 216
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)
- 030564A Exp Date 2017-11-30
- 031034A Exp Date 2017-11-30
- 0318321A Exp Date 2018-01-30
- 033317A Exp Date 2018-03-30
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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