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
Reported: October 12, 2016 Initiated: August 23, 2016 #Z-2907-2016
Product Description
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
Reason for Recall
During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.
Details
- Recalling Firm
- Integra LifeSciences Corp.
- Units Affected
- 18
- Distribution
- Nationwide Distribution to KS only
- Location
- Plainsboro, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Integra LifeSciences Corp.. Units affected: 18.
Why was this product recalled? ▼
During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 12, 2016. Severity: Moderate. Recall number: Z-2907-2016.
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