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A.t.s® 4000 ts tourniquet systems single and dual hose with cpc connectors

Official notice

23 Jun 2026

Last checked

23 Jun 2026

Medium riskHealth Canada
Watch Zimmer Surgical Also Trading Relign

An official Health Canada notice concerns A.t.s® 4000 ts tourniquet systems single and dual hose with cpc connectors. Zimmer Biomet is conducting a medical device recall for A.T.S® 4000 TS Tourniquet Systems Single and Dual Hose with CPC Connectors. One (1) complaint was received with no clinical impact reporting that wrinkles were identified in the sealing area of the sterile pouch. Subsequent seal integrity testing conducted internally showed potential sterility breach in 0.92% of inspected units that had visual seal nonconformities. The devices are distributed in cases (CS) of 20 units. Inside each case are two boxes (BX) of 10 units each. Published 2026-06-23.

What to do now

Contact the manufacturer if you require additional information.

Recall number

82244

Official notice

2026-06-23

The hazard

Zimmer Biomet is conducting a medical device recall for A.T.S® 4000 TS Tourniquet Systems Single and Dual Hose with CPC Connectors. One (1) complaint was received with no clinical impact reporting that wrinkles were identified in the sealing area of the sterile pouch. Subsequent seal integrity testing conducted internally showed potential sterility breach in 0.92% of inspected units that had visual seal nonconformities. The devices are distributed in cases (CS) of 20 units. Inside each case are two boxes (BX) of 10 units each.

How to check if you're affected

Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.

Lots

79701948, 80555938, 79701947, 80581870, 80765021, 79701946, 80555940, 80555939, 80581869

Skus

60-4009-101-00, 60-1812-101-00

Other

RA RA-82244

Model Numbers

60-4009-101-00, 60-1812-101-00

Recall Numbers

82244

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Affected products

Product 1

Lot or serial number - 79701948, Model or catalogue number - 60-4009-101-00

Product 2

Lot or serial number - 80555938, Model or catalogue number - 60-4009-101-00

Product 3

Lot or serial number - 79701947, Model or catalogue number - 60-4009-101-00

Product 4

Lot or serial number - 80581870, Model or catalogue number - 60-4009-101-00

Product 5

Lot or serial number - 80765021, Model or catalogue number - 60-4009-101-00

Product 6

Lot or serial number - 79701946, Model or catalogue number - 60-4009-101-00

Product 7

Lot or serial number - 80555940, Model or catalogue number - 60-4009-101-00

Product 8

Lot or serial number - 80555939, Model or catalogue number - 60-4009-101-00

Product 9

Lot or serial number - 80581869, Model or catalogue number - 60-4009-101-00

Product 10

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 60-1812-101-00

Risk / hazard

Zimmer Biomet is conducting a medical device recall for A.T.S® 4000 TS Tourniquet Systems Single and Dual Hose with CPC Connectors. One (1) complaint was received with no clinical impact reporting that wrinkles were identified in the sealing area of the sterile pouch. Subsequent seal integrity testing conducted internally showed potential sterility breach in 0.92% of inspected units that had visual seal nonconformities. The devices are distributed in cases (CS) of 20 units. Inside each case are two boxes (BX) of 10 units each.

Where it was sold

The source does not list specific retailers. See the official notice for where affected vehicles were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand

Zimmer Surgical Also Trading Relign

Manufacturer

Not provided

Phone

Not provided

Brand: Zimmer Surgical Also Trading Relign.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

82244

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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