Recall of VP Shunt Procedure Trays Due to Glove Splitting
Resource Optimization & Innovation LLC is recalling 55 VP Shunt procedure trays 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 field breach) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 55 kits of Regard VP Shunt procedure trays (Item Number: 800566002, Sterile, NU0655B). The recall affects trays distributed to Los Angeles and Texas, specifically those with lot codes 028743B (expiration date 2017-03-30) and 030250B (expiration date 2017-08-01).
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 and consumers who have these specific procedure trays should stop using them immediately and contact the recalling firm for instructions on return or disposal. The FDA has classified this as a Class II recall.
The recalled product
- Product
- Regard, Item Number: 800566002, Sterile, NU0655B - VP Shunt - Childrens Santa Rosa
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Affected units
- 55
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)
- 028743B Exp Date 2017-03-30
- 030250B Exp Date 2017-08-01
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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