Zimmer Surgical Inc: Brand Name: Sterile Tourniquet Hoses Product Name: A.t.s¿ 4000 Ts Tourniquet Systems Single Hose With Cpc Connectors Model/catalog Number: 60-4009-...
Recall Summary Zimmer Surgical is recalling A.T.S. 4000 TS Tourniquet Systems Single Hoses (model 60-4009-101-00) distributed worldwide because the sterile packaging may have a seal breach that could compromise sterility. If used in surgery, the hose could potentially cause a moderate localized infection, though if the problem is caught before use, the main impact would be a brief surgery delay while finding a replacement device.
- Recalling firm
- Zimmer Surgical Inc
- Product
- Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems Single Hose with CPC Connectors Model/Catalog Number: 60-4009-101-00 Software Version: N/A Product Description: Single 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/97691626-48cd-4ec9-a2c2-16cbe6f1c130