Recall of Regard Total Joint Procedure Kits Due to Glove Defect
Resource Optimization & Innovation LLC is recalling 208 Regard Total Joint 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 medical device defect that breaks the sterile field, creating a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 208 kits of Regard, Item Number: 800414003, Sterile, OR0483C - Total Joint Pk - Spohn. The recall affects kits with expiration dates of October 5, 2018, and November 23, 2018. These products were distributed to facilities in Louisiana and Texas.
The recall was initiated because the custom procedure 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 and contact the recalling firm for instructions on how to return or dispose of the affected products.
The recalled product
- Product
- Regard, Item Number: 800414003, Sterile, OR0483C - Total Joint Pk - Spohn
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Affected units
- 208
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)
- 038643C Exp Date 2018-10-05
- 039774C Exp Date 2018-11-23
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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