Recall of Regard Sterile Extremity Packs Due to Glove Splitting Risk
Resource Optimization & Innovation LLC is recalling 590 sterile extremity packs 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 medical device defect that breaks the sterile field, posing a risk of infection or harm, but no injuries or illnesses are reported in the source text.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 590 units of Regard, Item Number: 800525002 Sterile, OR0609B - Extremity Pack - Westover Hills. The recall involves specific lots with expiration dates of June 16, 2018, July 26, 2018, and October 10, 2018. These products were distributed to locations in California and Texas.
The recall was initiated 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 items should stop using them immediately and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Regard, Item Number: 800525002 Sterile, OR0609B - Extremity Pack - Westover Hills
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Affected units
- 590
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)
- 034267B Exp Date 2018-06-16
- 036852B Exp Date 2018-07-26
- 038768B 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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