Z-1354-2021Class II

CODMAN HAKIM BACTISEAL Shunt System Clear with Barium Stripe Peritoneal Catheter 120cm, with drainage Holes...

Name: Z-1354-2021 CODMAN HAKIM BACTISEAL Shunt System Clear with Barium Stripe Peritoneal Catheter 120cm, with drainage Holes...
Creator: Integra LifeSciences Corp.
Published: 2021-03-17
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2021-03-17 / Terminated / root cause: labeling and UDI

FDA source

Integra LifeSciences Corp. began a recall of CODMAN HAKIM BACTISEAL Shunt System Clear with Barium Stripe Peritoneal Catheter 120cm, with drainage Holes and Marking. For use in the treatment of... on 2021-03-17. FDA classified it as Class II and gives the reason as "Incorrect labeling, Catheter did not have the required holes and markings". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1354-2021
Classification: Class II
Status: Terminated
Initiated: 2021-03-17
Posted: 2021-04-05
Terminated: 2021-12-02
Recalling firm: Integra LifeSciences Corporation
Product: 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
Product code: HCA Catheter, Ventricular
Reason for recall: Incorrect labeling, Catheter did not have the required holes and markings
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: 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]
Quantity in commerce: 49 units
Distribution: CA CO FL KY MD NC NC NY NY TX WI
Product codes and lots: Lot Number: 5028205 UDI: (01)10381780526797 (17)210930(10)5028205

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1354-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1354-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-14	2021-04-05

Product code HCA

K031123Class IICodman Bactiseal Barium Striped CathetersCodman & Shurtleff, Inc. / cleared 2003-05-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)