Resource Optimization Recalls Sterile C-Section Kits Due to Glove Defect
Resource Optimization & Innovation LLC is recalling 430 sterile C-section kits because a light glove component may 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 risk-of-harm product (sterile field breach) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 430 sterile C-section kits (Item Number: 800408004, LD077D - C-Section PK - Spohn). The kits contain a light glove component that has been recalled by the manufacturer because it can split during application to a light handle.
The defect can break the sterile field, which is a critical safety requirement for surgical procedures. The affected lots have expiration dates of August 15, 2018, and September 29, 2018.
The product was distributed in the United States to California and Texas. Healthcare facilities should stop using these kits and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Regard, Item Number: 800408004, Sterile, LD0477D - C-Section PK - Spohn
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Affected units
- 430
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)
- 037438D Exp Date 2018-8-15
- 038495D Exp Date 2018-9-29
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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