US Endoscopy Recalls Roth Net Polyp Retrieval Due to Date Mismatch
US Endoscopy Group Inc is recalling Roth Net Polyp Retrieval devices because the expiration date on the outer carton is shorter than the date on the inner package.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which the rubric defines as typically scoring 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a documentation/packaging discrepancy regarding expiration dates.
Plain-English summary
US Endoscopy Group Inc is recalling 2,131 units of the Roth Net Polyp Retrieval device. The recall was initiated after the firm was notified that the expiration date printed on the outer carton differs from the expiration date on the inner package. Specifically, the expiration date on the outer carton is shorter than the actual expiration date indicated on the inner package.
The affected devices are Model # 0071151. The recall covers five specific lots: Lot # 1613898 (Exp. Date October 5, 2019), Lot # 1616337 (Exp. Date October 7, 2019), Lot # 1616733 (Exp. Date October 7, 2019), Lot # 1616734 (Exp. Date October 20, 2019), and Lot # 1616735 (Exp. Date October 28, 2019).
The product was distributed in the United States to the states of AL, CA, CO, IL, KS, MA, MT, NC, NE, NY, OH, PA, TN, TX, and WA. The product was also shipped to Australia, Belgium, Canada, Czech Republic, Ireland, Kuwait, Norway, Poland, and Sweden. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
The recalled product
- Product
- Roth Net Polyp Retrieval
- Manufacturer
- US Endoscopy Group Inc
- Category
- Medical Device — Endoscopy
- Hazard
- Affected units
- 2,131
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 (12)
- Model # 0071151
- Lot #s: 1613898
- Exp. Date October 5
- 2019
- Lot # 1616337
- Exp. Date October 7
- Lot # 1616733
- Lot # 1616734
- Exp. Date October 20
- 2019 & Lot # 1616735
- Exp. Date October 28
- 2019.
Distribution
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