Recall of Regard Sterile Open Heart Procedure Kits Due to Glove Defect
Resource Optimization & Innovation LLC is recalling 228 sterile open heart procedure kits 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 surgical kit) where a defect can break the sterile field, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 228 kits of the Regard, Item Number 800410005, Sterile, CV0479E- Open Heart PK - Spohn. These custom procedure trays were distributed to locations in California and Texas. The affected lots have expiration dates of April 30, 2018, June 30, 2018, and August 30, 2018.
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.
Healthcare facilities that have received these kits should stop using them immediately and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Regard, Item Number: 800410005, Sterile, CV0479E- Open Heart PK - Spohn
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Affected units
- 228
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 (3)
- 034408E Exp Date 2018-04-30
- 038488E Exp Date 2018-06-30
- 039730E Exp Date 2018-08-30
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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