Agency classClass IIOur severity:High FDA (Devices)·Z-1665-2017·Announced 2017-04-05

Recall of Spohn AV Access Kits Due to Splitting Light Gloves

Resource Optimization & Innovation LLC is recalling 306 Spohn AV Access Kits because the included light gloves can split, breaking 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 (splitting glove) breaks the sterile field, creating a risk of harm (infection) even though no specific injuries are reported in the source text.

Plain-English summary

Resource Optimization & Innovation LLC is recalling 306 units of the Regard, Item Number: 800425001, Sterile, CV0494A - AV Access Pk - Spohn. These custom procedure trays were distributed to locations in Louisiana and Texas.

The recall was initiated because the trays contain a component, a light glove, that has been recalled by the manufacturer. This glove can split during application to a light handle, which breaks the sterile field. The affected lots have expiration dates of January 4, 2018, March 11, 2018, May 5, 2018, and June 20, 2018.

Healthcare facilities should stop using these kits and contact the recalling firm for instructions on how to return or dispose of the product.

The recalled product

Product: Regard, Item Number: 800425001, Sterile, CV0494A - AV Access Pk - Spohn
Manufacturer: Resource Optimization & Innovation Llc
Category: Medical Device — Surgical Kits
Hazard: sterility-breach
infection-risk
Affected units: 306

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 (4)

030684A Exp Date 2018-01-04
032158A Exp Date 2018-03-11
033365A Exp Date 2018-05-05
034402A Exp Date 2018-06-20

Distribution

Distributed in 2 states:

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.

See all 135 products in this recall →

Same manufacturer · Resource Optimization & Innovation Llc

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Same hazard · sterility breach