Recall of Spohn Laparoscopy Kits Due to Light Glove Splitting
Resource Optimization & Innovation LLC is recalling 92 Spohn laparoscopy 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 where the sterile field can be broken, but the source text does not report any injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 92 kits of the Regard, Item Number: 800417002, Sterile, GY0486B - Laparoscopy Pk - Spohn. The recall involves specific lots with expiration dates of July 19, 2018, and October 17, 2018.
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.
The affected products were distributed in the United States to locations in Louisiana and Texas. The source text does not specify the exact number of affected units beyond the total of 92 kits, nor does it report any illnesses or injuries resulting from the use of these products.
The recalled product
- Product
- Regard, Item Number: 800417002, Sterile, GY0486B - Laparoscopy Pk - Spohn
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 92
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)
- 036643B Exp Date 2018-07-19
- 038943B Exp Date 2018-10-17
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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