Kittner gauze rolls had biological foreign matter and wrong pack quantity
Carefree Surgical Specialties Robotic/Laparoscopy Kittner Rolls Gauze is being recalled for product contamination with biological foreign matter that could compromise sterility, and an incorrect quantity of gauze in sterile packaging.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: Risk-of-harm product: biological foreign matter that could compromise sterility on gauze used inside the surgical field, with no infection reported.
Plain-English summary
Carefree Surgical Specialties Robotic/Laparoscopy Kittner Rolls Gauze, medium, 4 inches long, x-ray detectable, 5 per pack, 25 packs per case, catalog number 15505/25, is being recalled. The action covers 500 units from lot 1650.
The stated reason covers two issues: product contamination with biological foreign matter that could compromise sterility, and an incorrect quantity of gauze in the sterile packaging. The FDA classified the action as Class II. The source does not report any infection having occurred.
Distribution was nationwide in the United States, including Kentucky, Texas, Florida, North Carolina, Colorado, California, Idaho, West Virginia and New York. The gauze is supplied to surgical facilities rather than sold to consumers.
Facilities should identify affected stock using the catalog number and lot number above, quarantine it, and follow the instructions issued by the manufacturer.
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…
- Manufacturer
- Carefree Surgical Specialties
- Category
- Medical Device — Surgical gauze
- Affected units
- 500
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: 1650 UDI Code: Not Available
Distribution
Part of a larger recall action
This product is one of 4 recalled by Carefree Surgical Specialties 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.
See all 4 products in this recall →Related recalls
Same manufacturer · Carefree Surgical Specialties
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