Recall Z-2907-2016— Integra LifeSciences Corp.
Class II · Terminated
Class II FDA medical device recall by Integra LifeSciences Corp., initiated 2016-08-23, terminated 2017-03-29. It names one FDA 510(k) clearance: K924600. 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 package of lumbar catheter and Internal drainage set are finally packed in a cardboard box. Intended for CSF external drainage. Reason: During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product..
- Recalling firm
- Integra LifeSciences Corp.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-08-23
- Terminated
- 2017-03-29
- Firm location
- Plainsboro, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.