MoniTorr INS1100 INS-1100 CSF Drainage System used with… recallZ-1311-2019 · Integra LifeSciences Corp. · initiated Apr 8, 2019

Why it was recalled

The firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount stopcock and MoniTorr Panel Mount stopcock.

FDA root cause category: Device Design

What the company is doing

On April 8, 2019, the firm distributed Urgent Medical Device Correction letters to its affected customers. The communication advised customers of the possible breakage of the stopcock. Customers were advised to take the following precautions: When connecting a fluid-filled transducer (FFT) to the Panel Mount/Transducer Mount stopcocks: " Do not apply excessive force while attaching the FFT to the stopcock. " Take care during the priming process to not torque or bend the syringe and FFT. " Ensure luer lock is "finger tight;" do not over-tighten connection at the stopcock junction. When managing an external ventricular or lumbar drain (EVD) with a FFT attached: " Take care when manipulating the stopcock to zero the FFT and to obtain pressure readings, do not apply excessive force to the stopcock junction. " Use caution during patient transportation and during routine ICU care, to avoid direct contact of the FFT with other devices or equipment. " If the FFT must be flushed or replaced, do not apply excessive torque or force to the FFT/ stopcock junction. " If the FFT is connected to the ICU bedside monitor, ensure the interface cable is positioned so that it does not place excess force on the FFT (e.Q. do not allow cable to touch the floor. Customers were asked to determine if they had any affected product on hand, review and understand the precautions, and complete and return a completed acknowledgement form to the firm. Distributors were asked to forward the customer letter to any customers who received the affected product. Should you have any questions regarding these instructions, please contact Customer Service Monday to Friday 8:00 AM - 8:00 PM EST USA: 1-800-654-2873: email: [email protected] Outside USA: 781-565-1401 ***UPDATE*** On October 22, 2019, the firm sent out an updated notification informing customers that a new stopcock has been designed for the LimiTorr and MoniTorr, and is now available for replacement of th

Recall details

Recall number

Z-1311-2019

Recall class

Class I (most serious)

Status

Terminated

Initiated by the company

Apr 8, 2019

Posted by the FDA

May 20, 2019

Recalling firm

Integra LifeSciences Corp.

Quantity

42102 units

Product code

JXG

FDA submissions

K022554, K062599

Distribution

Worldwide Distribution - US Nationwide International distribution to Argentina, American Samoa, Australia, Canada, and Guam.

Product description

MoniTorr INS1100 INS-1100 CSF Drainage System used with Pole Mount System Product Usage: The MoniTorr ICP External CSF Drainage and Monitoring Systems provide a simple to use, closed system for the drainage of cerebrospinal fluid (CSF) from ventricles of the brain or the lumbar subarachnoid space to a drainage bag. The system may be used with a pole mounted assembly that allows for simple, quick and accurate alignment with the patient and secure positive or negative pressure level setting. The system also has been designed to provide for ease of patient transport through a compact design and antimicrobial hydrophobic vent feature that resists occlusion. Indications: The MoniTorr ICP system allows for drainage and monitoring of CSF from the lateral ventricles of the brain and the lumbar subarachnoid space in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF inpatients with infected CSF shunts, and to monitor ICP.

Other devices under the same FDA submission

3 devices cleared under K022554, K062599 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

• MoniTorr™ 10110

  Integra Lifesciences Corporation · Shunt, central nervous system and components
  2 reports
• MoniTorr™ 10100

  Integra Lifesciences Corporation · Shunt, central nervous system and components
  1 report
• MoniTorr™ INS1100

  Integra Lifesciences Corporation · Shunt, central nervous system and components
  1 report

Other products in the same recall event

The FDA groups related products into one recall event (event 82659).

• Z-1310-2019 · Terminated
  MoniTorr 10100 10-100 CSF Drainage System w/Patient Line One Way Valve MoniTorr 10102 10-102 CSF Drainage System w/Patient Line One Way Valve w MoniTorr 10110 10-110 CSF Drainage…
• Z-1312-2019 · Terminated
  LimiTorr INS9020 INS-9020 LIMITORR VOLUME LIMITING EVD 20 ML LimiTorr INS9020SP1 INS-9020SP1 LIMITORR VOLUME EVD 20ML LimiTorr INS9030 INS-9030 LIMITORR VOLUME LIMITING EVD 30 ML…