Integra Ventricular Catheter Accessory Kit Recalled for Incomplete Packaging Seal
Integra LifeSciences Corp. is recalling 14 units of the Ventricular Catheter Accessory Kit due to an incomplete sterile packaging seal discovered during final inspection.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a sterile medical device with a compromised seal, creating a risk of infection or harm to patients, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Integra LifeSciences Corp. is recalling 14 units of the Integra Ventricular Catheter Accessory Kit, REF 951303. The specific lot affected is #0195786, with an expiration date of 05/2019. The product is a sterile, prescription-only medical device used with CSF external drainage systems.
The recall was initiated after a final sampling inspection revealed that one of the lots had a total incomplete packaging seal on the sterile product. This defect compromises the sterile integrity of the device.
The affected units were distributed nationwide to Kansas only. Healthcare providers and facilities that have received this specific lot should stop using the product and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Integra Ventricular Catheter Accessory Kit, REF 951303, Sterile EO, Rx only, packaged in a PVC tray, then secondary package in to Tyvek pouch and tertiary packaged in to Tyvek pouch. Sealed pouches are packaged in a cardboard box. F8 35cm Silicone Elastomer Ventricular…
- Manufacturer
- Integra LifeSciences Corp.
- Affected units
- 14
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Catalog Number 951303
- Lot #0195786 with expiry 05/2019
Distribution
Part of a larger recall action
This product is one of 6 recalled by Integra LifeSciences Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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