FDAFDA · Food and drugs·Recall number Z-2907-2016
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 package of lumbar catheter and Internal drainage set are finally packed in a cardboard box. Intended for CSF external drainage
Published October 12, 2016 · Recall initiated: August 23, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Integra LifeSciences Corp.
- Distributor
- Nationwide Distribution to KS only
- Lot
- Catalog Number 910420, Lot #0195878 with expiry 10/2018
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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