Agency classClass IIOur severity:Severe FDA (Devices)·Z-1580-2017·Announced 2017-04-05

Recall of Regard Open Heart Procedure Kits Due to Glove Splitting

Resource Optimization & Innovation LLC is recalling 117 sterile open heart procedure kits because a light glove component 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this as a Class II recall. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects in medical devices that compromise sterility, are rated as Severe (4).

Plain-English summary

Resource Optimization & Innovation LLC is recalling 117 units of the Regard, Item Number: 800410003, Sterile, CV0479C - Open Heart PK - Spohn. These are custom procedure trays intended for open heart procedures. The affected lots have expiration dates of March 30, 2017, with codes 028316C and 028909C.

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 agency has classified this as a Class II recall.

The affected products were distributed in the United States to locations in California (LA) and Texas (TX). Healthcare facilities that have received these specific kits should stop using them and contact the recalling firm for instructions on return or disposal.

The recalled product

Product: Regard, Item Number: 800410003, Sterile, CV0479C - Open Heart PK - Spohn
Manufacturer: Resource Optimization & Innovation Llc
Category: Medical Device — Surgical Kits
Hazard: sterile-field-breach
component-failure
Affected units: 117

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 (2)

028316C Exp Date 2017-03-30
028909C Exp Date 2017-03-30

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 →

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Same hazard · sterile field breach