Zimmer Surgical Inc: Brand Name: Sterile Tourniquet Hoses Product Name: A.t.s¿ 4000 Ts Tourniquet Systems Dual Hose With Cpc Connectors Model/catalog Number: 60-1812-10...
- Recalling firm
- Zimmer Surgical Inc
- Product
- Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems Dual Hose with CPC Connectors Model/Catalog Number: 60-1812-101-00 Software Version: N/A Product Description: Dual Sterile Extension Hose with PLC Connector Component: N/A
- Reason
- Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find another readily available device.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-06-09
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada and EMEA.
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/62cb916d-4b5e-412f-8535-096645029555