Recall of Regard Sterile Neuro PK Spohn Procedure Trays
Resource Optimization & Innovation Llc is recalling 1,056 sterile procedure trays because a light glove component can split and break 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 sterile medical device where a defect can break the sterile field, creating a risk of infection or harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Resource Optimization & Innovation Llc is recalling 1,056 units of Regard, Item Number: 800411002, Sterile, NU0480B- Neuro PK - Spohn 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, which breaks the sterile field. The affected lots have expiration dates ranging from March 30, 2017, to April 30, 2018. The products were distributed to locations in Louisiana and Texas.
Healthcare facilities should stop using the affected trays and contact the manufacturer for further instructions.
The recalled product
- Product
- Regard, Item Number: 800411002, Sterile, NU0480B- Neuro PK - Spohn
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Affected units
- 1,056
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)
- 027522B Exp Date 2017-03-30
- 030020B Exp Date 2017-10-30
- 031641B Exp Date 2017-12-30
- 033142B Exp Date 2017-12-30
- 034112B Exp Date 2018-04-30
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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