Recall of Regard Sterile Abdominal Procedure Kits Due to Glove Defect
Resource Optimization & Innovation LLC is recalling 210 sterile abdominal procedure kits because a light glove component may split during use, 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 field breach) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 210 units of Regard sterile abdominal procedure kits (Item Number: 800533001, GS0606A). The affected kits have an expiration date of 2017-12-17 and were distributed to locations in California and Texas.
The recall was initiated because the kits 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 specific kits should stop using them and contact the recalling firm for instructions on how to return or dispose of the product.
The recalled product
- Product
- Regard, Item Number: 800533001, Sterile, GS0606A - Abdominal Pk - Westover Hills
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Affected units
- 210
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 (1)
- 030102A Exp Date 2017-12-17
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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