Carefree Robotic/Laparoscopy Kittner Rolls Gauze recalled for contamination and incorrect quantity
Carefree Surgical Specialties is recalling Robotic/Laparoscopy Kittner Rolls Gauze (Lot 1645) due to biological foreign matter contamination and incorrect quantity in sterile packaging, affecting 500 units distributed nationwide.
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: This is an FDA Class II medical device recall involving biological contamination of sterile surgical gauze. The source text does not report any illnesses or injuries. Per the severity rubric, this is classified as a risk-of-harm product where injury has not yet been reported, warranting a High severity score.
Plain-English summary
Carefree Surgical Specialties is recalling Robotic/Laparoscopy Kittner Rolls Gauze (Model 15505/25), Medium 4" Long, X-Ray Detectable (5 per package, 25 per case). Lot Number 1645 is affected, involving 500 units distributed nationwide.
The recall is due to two identified defects: biological foreign matter contamination that could compromise the product's sterility, and an incorrect quantity of gauze in sterile packaging.
This surgical gauze is used in robotic and laparoscopic procedures. Affected facilities and providers should stop using the affected lot immediately and contact Carefree Surgical Specialties for instructions regarding return or replacement of the product.
The recalled product
- Product
- Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray Detectable 5/pk 25pk/CS Model/Catalog Number: 15505/25 Product Description: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray Detectable 5/pk 25pk/
- Manufacturer
- Carefree Surgical Specialties
- Hazard
- sterility-compromise
- biological-contamination
- incorrect-quantity
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 (1)
- Lot Code: Lot Number: 1645 UDI Code: Not Available
Distribution
Distributed nationwide across the United States.
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