Recall of Regard Sterile Extremity Packs Due to Glove Splitting Risk
Resource Optimization & Innovation LLC is recalling 456 sterile extremity packs because a light glove component may split, breaking the sterile field.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 theoretical hazards without confirmed illness.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 456 kits of Regard sterile extremity packs (Item Number: 800525001, OR0609A - Westover Hills). The affected products were distributed to locations in Louisiana and Texas. The recall involves specific lots with expiration dates of January 21, 2018, March 2, 2018, and April 19, 2018.
The recall is being conducted because the custom procedure 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 surgical procedures.
Healthcare facilities and consumers who have these specific sterile packs should stop using them immediately. The manufacturer has initiated the recall to address this potential breach of sterility.
The recalled product
- Product
- Regard, Item Number: 800525001, Sterile, OR0609A - Extremity Pack - Westover Hills
- Manufacturer
- Resource Optimization & Innovation Llc
- Affected units
- 456
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 (3)
- 031066A Exp Date 2018-01-21
- 031996A Exp Date 2018-03-02
- 033021A Exp Date 2018-04-19
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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