Recall of Regard Sterile Lap Chole Kits Due to Glove Splitting
Resource Optimization & Innovation LLC is recalling 834 sterile lap chole 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 where a defect (glove splitting) breaks the sterile field, creating a risk of harm through potential infection, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 834 kits of Regard, Item Number: 800528002 Sterile, GS0612B - Lap Chole PK - Westover Hills. The recall is due to a defect in a light glove component included in the custom procedure trays.
The light glove can split during application to a light handle. This failure breaks the sterile field, which is a critical safety requirement for surgical procedures. The affected lots have expiration dates ranging from August 30, 2017, to November 30, 2017.
The product was distributed in the United States to locations in Louisiana and Texas. Healthcare facilities that have received these kits should stop using them and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Regard, Item Number: 800528002 Sterile, GS0612B - Lap Chole PK - Westover Hills
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Affected units
- 834
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)
- 027929B Exp Date 2017-08-30
- 029240B Exp Date 2017-09-30
- 030080B Exp Date 2017-10-30
- 031818B Exp Date 2017-11-30
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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