Microline Surgical, Inc.: TLS2 Thermal Ligating Shears, Catalog Number 132-131D

Is my product affected?

TLS2 Thermal Ligating Shears, Catalog Number 132-131D

• UPC 811099011439

Check against the official notice below — it lists the full affected range.

What happened

Microline Surgical, Inc. is recalling 115 units of its TLS2 Thermal Ligating Shears (Catalog Number 132-131D) because the shears experience a high rate of complete or intermittent failure to actuate, meaning they do not perform their intended surgical function. The affected products were distributed to North Dakota and New York in the United States, as well as to Germany and the Netherlands. The recalled units are identified by UDI 811099011439 and Lot Numbers 807118, 807119, 807120, and 811076.

The recall record does not specify a remedy or what action affected consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

The shears exhibited a high rate of complete or intermittent failure to actuate. As a result, they do not perform their intended function in surgical procedures.

Details from the source

Reason for recall: The shears exhibited a high rate of complete or intermittent failure to actuate. As a result, they do not perform their intended function in surgical procedures. Distribution: The products were distributed to the following US states: ND and NY. The products were distributed to the following foreign countries: Germany, Netherlands. Quantity: 115 units Lot/code info: UDI: 811099011439; Lot Numbers: 807118, 807119, 807120, 811076

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• Biomerieux Vitek 2 Test kit VITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.2019-03-15
• Innova IGS 630, Interventional Fluoroscopic X-Ray System used in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.2019-03-15
• Prestige II, Prestige SI, Prestige VH Prestige system is a new multi-purpose conventional and digital R/F remote controlled system.2019-03-29
• SHERPA NX ACTIVE GUIDING CATHETER, 6F, IMA 55CM .070", REF SA6IMAK. for cardiovascular use2019-03-15
• SHERPA NX ACTIVE GUIDING CATHETER, 6F, RDND1 55CM .070", REF SA6RDND1K. for cardiovascular use2019-03-15

All FDA (Device enforcement) recalls