Recall of Regard Sterile Lap Chole Procedure Kits Due to Glove Defect
Resource Optimization & Innovation LLC is recalling 2,016 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 High severity criteria.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 2,016 units of the Regard, Item Number: 800409002, Sterile, GS0478B - Lap Chole PK - Spohn. These are custom procedure trays distributed to locations in California and Texas.
The recall is being conducted because the trays contain a light glove component that has been recalled by the manufacturer. This component can split during application to a light handle, which breaks the sterile field. The affected lots have expiration dates ranging from August 14, 2017, to May 3, 2018.
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: 800409002, Sterile, GS0478B - Lap Chole PK - Spohn
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Affected units
- 2,016
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 (6)
- 027525B Exp Date 2017-08-14
- 028915B Exp Date 2017-10-19
- 030195B Exp Date 2017-12-21
- 031255B Exp Date 2018-01-29
- 032688B Exp Date 2017-09-30
- 033330B Exp Date 2018-05-03
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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