The Recall Desk
ModerateFDA (Devices)·Z-2910-2016·Announced 2016-10-12

Integra Lumbar Drainage Set Recalled Due to Incomplete Packaging Seal

Integra LifeSciences Corp. is recalling specific lots of Lumbar Drainage Sets because final inspection revealed an incomplete packaging seal on the sterile product.

What this means for you

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 is a packaging defect that compromises sterility, which is a significant risk but does not meet the criteria for Class I (death/serious injury) or High (high-risk pathogens/allergens).

Plain-English summary

Integra LifeSciences Corp. is recalling the Integra Lumbar Drainage Set, Catalog Number 910120A, Lot #0195870, with an expiration date of 05/2019. The recall is limited to one sealed package of the lumbar catheter and external drainage system.

The recall was initiated after final sampling inspection discovered that one of the lots had a total incomplete packaging seal of the sterile product. This defect compromises the sterile integrity of the device, which is intended for cerebrospinal fluid (CSF) external drainage.

The affected product was distributed nationwide to Kansas only. The device is prescription-only and is packaged in a PVC blister sealed with a Tyvek sheet, secondary packaged in a Tyvek pouch, and finally packaged in a cardboard box. Users should stop using the affected lots and contact their healthcare provider or the manufacturer for instructions on replacement or return.

The recalled product

Product
Integra Lumbar Drainage Set, REF 910120A, Sterile EO, Rx only, primary packaged in a PVC blister sealed with Tyvek sheet and secondary packaged in to Tyvek pouch. External drainag system is primary packaged in a Tyvek pouch and secondary packaged in to Tyvek pouch. One (1) sealed
Manufacturer
Integra LifeSciences Corp.
Category
Medical Device — Surgical / Drainage
Hazard
Affected units
1

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 910120A
  • Lot #0195870 with expiry 05/2019

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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.

See all 6 products in this recall →

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