Recall of Spohn Total Joint PK Procedure Trays Due to Glove Defect
Resource Optimization & Innovation LLC is recalling 86 sterile Total Joint PK 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.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 86 sterile procedure trays, identified as Regard Item Number 800414001 (OR0483A - Total Joint PK - Spohn). 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, which breaks the sterile field. This defect poses a risk of contamination during surgical procedures. The affected units have an expiration date of 2017-09-21 and a code of 028252A.
The recalled trays were distributed in the United States to locations in Louisiana and Texas. Healthcare facilities and users should stop using these specific trays and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Regard, Item Number: 800414001, Sterile, OR0483A - Total Joint PK - Spohn
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Affected units
- 86
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)
- 028252A Exp Date 2017-09-21
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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