Integra LifeSciences recalls Bactise:al Ventricular Catheter (823073) mislabeled as Bactiseal Endoscopic Ventricular Catheter (823087). This could lead to incorrect use in hydrocephalus treatment. Affected units: Lot 4178253, exp. Nov 2019.
Mislabeled product-Bactiseal Ventricular Catheter with Bactiseal Shunt System(823073) mislabeled as Bactiseal Endoscopic Ventricular Catheter (823087) and vs. versa
Integra LifeSciences recalls a specific ventricular catheter model that was mislabeled. Using the wrong product could cause incorrect treatment for hydrocephalus, which is serious.
The catheter was mislabeled as a different model, which could lead to incorrect use in hydrocephalus treatment. This might cause improper drainage of cerebrospinal fluid, potentially affecting patient outcomes.
Patients using hydrocephalus shunt systems with this specific catheter model are affected. Healthcare providers who administered the mislabeled product are at highest risk.
Check for part number 823073 on the catheter. The lot number 4178253 was produced for expiration November 2019. This product is used for hydrocephalus treatment.
Look for part number 823073 and lot number 4178253 on the catheter.
The product itself is not dangerous, but mislabeling could lead to incorrect use in hydrocephalus treatment.
Check the product label for part number 823073 and lot number 4178253. If you have the correct product, no action is needed.
This product was manufactured with lot number 4178253 and expires November 2019.
We’ve drafted a message you can send Integra LifeSciences to request your refund or repair — edit it as you like.
Subject: Recall Z-0724-2021 — Integra LifeSciences Integra LifeSciences Hello, I own a Integra LifeSciences that is covered by recall Z-0724-2021 from Integra LifeSciences. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
