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MoniTorr 10100 10-100 CSF Drainage System w/Patient Line… recallZ-1310-2019 · Integra LifeSciences Corp. · initiated Apr 8, 2019

Class I Terminated All recalls posted in May 2019

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Integra LifeSciences Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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-1310-2019
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, K920156, K062599
Distribution
Worldwide Distribution - US Nationwide International distribution to Argentina, American Samoa, Australia, Canada, and Guam.

Product description

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 System used with Pole Mount System MoniTorr 10140 10-140 CSF Drainage System w/Vinyl Measuring Strip MoniTorr 10150 10-150 CSF Drainage System Simple Bag and Line MoniTorr 10110A 10-110A CSF Drainage System w/o Manifold Stopcock MoniTorr SP0017 SP0017 Special EVD 10-110 w/o Y Site Latex Free Sites MoniTorr SP0042 SP0042 Special EVD 10-100 w/o Y Site MoniTorr SP0090 SP0090 Special EVD 10-110 w/o Y Site MoniTorr SP0164 SP0164 Special EVD 10-140 w/Y Site & Stopcock Reverse MoniTorr SP0236 SP0236 INS 1100 WITH NEEDLE AT Y-ACCESS AND NEEDLELESS SI 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.

Code information (models, lots, serial numbers)

All lots

Other devices under the same FDA submission

3 devices cleared under K022554, K920156, 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.

Other products in the same recall event

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

Sources and updates

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