Recall of Sterile Lap Chole Procedure Kits Due to Glove Splitting
Resource Optimization & Innovation LLC is recalling 1,224 sterile lap chole 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 field breach) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 1,224 units of the Regard, Item Number: 800409003, Sterile, GS0478B - Lap Chole PK - Spohn. These are custom procedure trays distributed in the United States to locations in Louisiana and Texas. The affected lots have expiration dates ranging from June 25, 2018, to December 09, 2018.
The recall was initiated because the trays contain a light glove component that has been recalled by the manufacturer. This specific component can split during application to a light handle. If the glove splits, it breaks the sterile field, which is a critical safety requirement for surgical procedures.
Healthcare facilities that have received these kits should stop using them immediately. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Regard, Item Number: 800409003, Sterile, GS0478B - Lap Chole PK - Spohn
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Affected units
- 1,224
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 (4)
- 034494C Exp Date 2018-06-25
- 037642C Exp Date 2018-08-25
- 038956C Exp Date 2018-10-19
- 040142C Exp Date 2018-12-09
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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