Recall of Regard Sterile Laparoscopic Procedure Kits Due to Glove Defect
Resource Optimization & Innovation LLC is recalling 5,000 sterile laparoscopic 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 medical device defect that breaks the sterile field, creating a risk of infection or other harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 5,000 kits of the Regard, Item Number: 800401001, Sterile, GS0470A - Lap PK - Spohn. These are custom procedure trays used for laparoscopic procedures. The recall was initiated because the trays contain a light glove component that has been recalled by the manufacturer.
The light glove 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 lots have expiration dates ranging from September 16, 2017, to May 19, 2018. The products were distributed to facilities in California and Texas.
Healthcare facilities that have received these kits should stop using them immediately and contact the recalling firm for instructions on return or disposal. Patients who have already had procedures using these kits should contact their healthcare provider if they have concerns about the integrity of the sterile field during their surgery.
The recalled product
- Product
- Regard, Item Number: 800401001, Sterile, GS0470A - Lap PK - Spohn
- Manufacturer
- Resource Optimization & Innovation Llc
- Affected units
- 5,000
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 (10)
- 028131A Exp Date 2017-09-16
- 028606A Exp Date 2017-10-13
- 029244A Exp Date 2017-11-02
- 029917A Exp Date 2017-12-08
- 030686A Exp Date 2018-01-04
- 031323A Exp Date 2018-02-01
- 031824A Exp Date 2018-02-24
- 032567A Exp Date 2018-03-31
- 033054A Exp Date 2018-04-21
- 033680A Exp Date 2018-05-19
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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