Sterile Tourniquet Hoses Recalled Due to Potential Sterility Breach
Zimmer Surgical Inc is recalling A.T.S. 4000 TS Tourniquet Systems Dual Hose with CPC Connectors due to a potential sterility breach in the sealing area of the sterile pouch. If used, the issue may result in moderate localized infection.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The FDA classified this as Class II. The source text explicitly describes the hazard as "potential" and a "may result" in "moderate localized infection"—a theoretical risk without reported illnesses. This fits the Moderate category for minor device-function issues without confirmed adverse events.
Plain-English summary
Zimmer Surgical Inc is recalling A.T.S. 4000 TS Tourniquet Systems Dual Hose with CPC Connectors (Model 60-1812-101-00) distributed worldwide, including the US, Canada, and EMEA countries. The affected units involve a potential sterility breach in the sealing area of the sterile pouch.
If used, this defect may result in moderate localized infection. If the issue is discovered prior to use, it may result in clinically insignificant extension of surgery to find another readily available device.
Healthcare facilities and providers who have received these tourniquets should check their inventory against the affected lot numbers provided and verify the sterility of pouches before use. If you have used one of these devices, consult with your healthcare facility regarding any potential patient monitoring or follow-up.
The recalled product
- 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
- Manufacturer
- Zimmer Surgical Inc
- Affected units
- 45,160
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 (20)
- Lot Code: Model No. 60-1812-101-00
- Case (20-pack) UDI (01)00889024381162(17)271125(10)78938271
- Box (10-Pack) UDI (01)00889024378469(17)271125(10)78938271
- Individual UDI (01)00889024367173(17)271125(10)78938271
- Lot Number 78938271 Model No. 60-1812-101-00
- Case (20-pack) UDI (01)00889024381162(17)271126(10)78938272
- Box (10-Pack) UDI (01)00889024378469(17)271126(10)78938272
- Individual UDI (01)00889024367173(17)271126(10)78938272
- Lot Number 78938272 Model No. 60-1812-101-00
- Case (20-pack) UDI (01)00889024381162(17)271127(10)78938273
- Box (10-Pack) UDI (01)00889024378469(17)271127(10)78938273
- Individual UDI (01)00889024367173(17)271127(10)78938273
- Lot Number 78938273 Model No. 60-1812-101-00
- Case (20-pack) UDI (01)00889024381162(17)280206(10)80555986
- Box (10-Pack) UDI (01)00889024378469(17)280206(10)80555986
- Individual UDI (01)00889024367173(17)280206(10)80555986
- Lot Number 80555986 Model No. 60-1812-101-00
- Case (20-pack) UDI (01)00889024381162(17)280102(10)80555987
- Box (10-Pack) UDI (01)00889024378469(17)280102(10)80555987
- Individual UDI (01)00889024367173(17)280102(10)80555987
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Zimmer Surgical Inc 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 2 products in this recall →Related recalls
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