Recall of Regard Ortho Pk Spohn Custom Procedure Trays Due to Glove Defect
Resource Optimization & Innovation LLC is recalling 2,122 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 medical devices with potential for infection or complications.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 2,122 units of Regard, Item Number: 800407003, Sterile, OR0476C - Ortho Pk - Spohn custom procedure trays. The affected product is a sterile orthopedic procedure kit distributed in the United States to locations in Louisiana and Texas.
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 for surgical procedures.
The source text does not specify specific actions for consumers or healthcare providers, such as whether to stop using the product or contact the manufacturer. The recall number is Z-1548-201.
The recalled product
- Product
- Regard, Item Number: 800407003, Sterile, OR0476C - Ortho Pk - Spohn
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Affected units
- 2,122
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 (5)
- 029388C Exp Date: 2017-11-09
- 030253C Exp Date: 2017-12-30
- 032103C Exp Date: 2018-03-07
- 033169C Exp Date: 2018-04-26
- 034466C Exp Date: 2018-06-22
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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