Lower riskMedical device recall · FDA · Published March 17, 2021
Integra CODMAN HAKIM BACTISEAL Shunt System: Incorrect Labeling Risk
Integra LifeSciences recalls CODMAN HAK: BACTISEAL shunt systems with incorrect labeling that may affect peritoneal catheter function. Learn if your device is affected and what to do.
“Integra CODMAN HAKIM BACTISEAL Shunt System: Incorrect Labeling Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63047-integra-codman-hakim-bactiseal-shunt-system-incorrect-labeling-risk. Based on FDA recall #Z-1354-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1354-2021%22&limit=1).
Integra LifeSciences Corp. recalled CODMAN HAKIM BACTISEAL Shunt System Clear with Barium Stripe Peritoneal Catheters due to incorrect labeling, the FDA said on March 17, 2021. The hazard involves catheters lacking required holes and markings.
How to tell if you have it
CODMAN HAKIM BACTISEAL Shunt System Clear with Barium Stripe Peritoneal Catheter 120cm, with drainage Holes and
UPC: 10381780526797
Lot Number: 5028205
Catalog Number: NS5524
The hazard
The recall addresses incorrect labeling where the catheter did not have the required holes and markings. The product is intended for use in the treatment of hydrocephalus.
Context
GovInfoNow's records show Integra LifeSciences Corp. has 35 other recalls on record since August 18, 2017. Recent brand recalls include an AURORA Surgiscope System recall on February 6, 2025, and a MediHoney Wound Dressing Gel recall on January 10, 2025. Other recent recalls of similar products include a GORE VIABIL Short Wire Biliary Endoprosthesis recall (May 22, 2026), a FARASTAR Ablation Generator recall (June 11, 2026), and a Codman CerebroFlo EVD Catheter recall (April 10, 2026).
How to tell if you have this one
Check for the model name 'CODMAN HAKIM BACTISEAL Shunt System Clear with Barium Stripe Peritoneal Catheter 120cm' and lot number 5028205. The product was sold with catalog number NS5524.
Brand
Integra LifeSciences
Product
CODMAN HAKIM BACTISEAL Shunt System Clear with Barium Stripe Peritoneal Catheter 120cm, with drainage Holes and
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the lot number and catalog number to confirm if your device is affected.
Where it went and when
Where it was distributed
Distributed in 9 states.
Listed by the agency
Not listed
FDA distribution: “CA CO FL KY MD NC NC NY NY TX WI” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Colorado, Florida, Kentucky, Maryland, New York, North Carolina, Texas, Wisconsin.
Recall timeline
FDA terminated this recall 9 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1354-2021 (March 17, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1354-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.