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.
What this means for you
Illness, injury, or structural failure has been reported. 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
- 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
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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