Recall of Regard Ortho PK Spohn Custom Procedure Trays Due to Glove Defect
Resource Optimization & Innovation Llc is recalling 460 Regard Ortho PK Spohn 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 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 460 kits of Regard, Item Number: 800407002, Sterile, OR0476B - Ortho PK - Spohn custom procedure trays. The recall is due to a defect in a light glove component included in the trays.
The light glove can split during application to a light handle. This failure breaks the sterile field, which is a critical safety requirement for surgical procedures. The affected product has an expiration date of 2017-08-12 and code 027476B.
The product was distributed in the United States to locations in Louisiana and Texas. No specific illnesses or injuries have been reported in the source text. Healthcare facilities should stop using these trays and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Regard, Item Number: 800407002, Sterile, OR0476B - Ortho PK - Spohn
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Affected units
- 460
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 (1)
- 027476B Exp Date 2017-08-12
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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