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CODMAN HAKIM BACTISEAL Shunt System Clear with Barium… recallZ-1354-2021 · Integra LifeSciences Corp. · initiated Mar 17, 2021

Terminated

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

Incorrect labeling, Catheter did not have the required holes and markings

FDA root cause category: Labeling Change Control

What the company is doing

Integra LifeSciences issued Voluntary Urgent Medical Device Recall letter via courier service, facsimile or email on March 17th for delivery on March 19th, 2021. Letter states reason for recall, health risk and action to take: If you do have the affected product in Table 1, remove the product from service. b. Complete the attached acknowledgement form. If you do have affected product, check the box I do have affected product. Record the total quantity of the affected product you have. c. If you do not have affected product, check the box, I do not have affected product. d. Return the completed acknowledgement form to [email protected] or FAX to 1-609-750-4220 e. Keep a copy of the form for your records. f. When your form is received, and it is noted that you have the affected product, Customer Service will contact you and provide a Return Material Authorization (RMA) number and directions to return the product. A replacement order will also be placed for the quantity noted on the form. Receipt of the acknowledgement form ensures that Integra has achieved a level of effectiveness in communicating this information effectively. We recommend you also maintain a copy of this notification and signed copy of the acknowledgement forms for your records. Regulatory agencies such as the FDA perform audits of field actions of this nature to verify that our customers have been notified and understand the nature of the field action. Should you have any questions regarding these instructions, please contact Customer Service: USA: 800-654-2873 Monday- Friday 8:00AM EST 6:00PM EST [email protected]

Recall details

Recall number
Z-1354-2021
Status
Terminated
Initiated by the company
Mar 17, 2021
Posted by the FDA
Apr 5, 2021
Recalling firm
Integra LifeSciences Corp.
Quantity
49 units
Product code
HCA
FDA submissions
K031123
Distribution
CA CO FL KY MD NC NC NY NY TX WI

Product description

CODMAN HAKIM BACTISEAL Shunt System Clear with Barium Stripe Peritoneal Catheter 120cm, with drainage Holes and Marking. For use in the treatment of hydrocephalus. Catalog Number: NS5524

Code information (models, lots, serial numbers)

Lot Number: 5028205  UDI: (01)10381780526797 (17)210930(10)5028205

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

3 devices cleared under K031123 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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