Integra Lumbar Drainage Set Recalled for Incomplete Packaging Seal
Integra LifeSciences is recalling 18 units of Integral Lumbar Drainage Sets due to incomplete sterile packaging seals 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a packaging defect that compromises sterility, which is a moderate risk but does not meet the criteria for Severe (Class II with hospitalization) or Critical (Class I).
Plain-English summary
Integra LifeSciences Corp. is recalling 18 units of the Integral Lumbar Drainage Set, Catalog Number 910420, Lot #0195878. The product is intended for CSF external drainage and is sterile, ethylene oxide (EO) sterilized, and prescription-only.
The recall was initiated because a total incomplete packaging seal of the sterile product was discovered during final sampling inspection. The affected units were distributed nationwide to Kansas only.
Healthcare providers and consumers should stop using the affected product and contact the manufacturer for further instructions.
The recalled product
- Product
- Integral Lumbar Drainage Set, REF 910420, Sterile EO, Rx only, primary packaged in a PVC blister sealed with Tyvek sheet and secondary packaged in to Tyvek pouch. Internal drainage set is primary packaged in a Tyvek pouch and secondary packaged in to Tyvek pouch, One (1) sealed…
- Manufacturer
- Integra LifeSciences Corp.
- Affected units
- 18
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 910420
- Lot #0195878 with expiry 10/2018
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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