Carefree Surgical Robotic Laparoscopy Kittner Gauze Recalled for Contamination
Carefree Surgical Specialties is recalling Robotic/Laparoscopy Kittner Roll Gauze due to biological contamination that could compromise sterility and incorrect quantity in sterile packaging.
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 recall of a sterile surgical device with biological contamination that could compromise sterility. Since no illnesses or injuries have been reported and the hazards are theoretical, the score is 3 per the rubric criteria for risk-of-harm products without reported injury.
Plain-English summary
Carefree Surgical Specialties is recalling Robotic/Laparoscopy Kittner Roll Gauze + Tail Medium 4" Long X-Ray Detectable (Model 15506/25, Lot 1607). The recall affects 65 units distributed nationwide across multiple states.
The recall was initiated due to biological foreign matter contamination that could compromise the sterility of the product, and incorrect quantity of gauze in sterile packaging.
Healthcare facilities and surgical centers that received affected units should immediately cease use and contact Carefree Surgical Specialties and the FDA for instructions regarding return or disposal of the recalled product.
The recalled product
- Product
- Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Roll Gauze + Tail Medium 4 Long X-Ray Detectable 5pk 25pk/CS Roll Gauzes Model/Catalog Number: 15506/25 Product Description: Robotic/Laparoscopy Kittner Roll Gauze + Tail Medium 4 Long X-Ray
- Manufacturer
- Carefree Surgical Specialties
- Hazard
- biological-contamination
- sterility-compromise
- 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: 1607 UDI Code: Not Available
Distribution
Distributed nationwide across the United States.
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