Recall Z-2906-2016— Integra LifeSciences Corp.
Class II · Terminated
Class II FDA medical device recall by Integra LifeSciences Corp., initiated 2016-08-23, terminated 2017-03-29. FDA's recall record names no specific 510(k) clearance for this event. Product: CUSA Dissectron Fingertip Laparoscopic Cannula, REF F75221, Sterile EO, Rx only, packaged in a Tyvek pouch and secondary packaged in Tyvek pouch, Five (5) sealed pouches are packaged in a cardboard box. For use with CUSA DISSECTRON Hand pieces and Sontrodes. 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
Product description
CUSA Dissectron Fingertip Laparoscopic Cannula, REF F75221, Sterile EO, Rx only, packaged in a Tyvek pouch and secondary packaged in Tyvek pouch, Five (5) sealed pouches are packaged in a cardboard box. For use with CUSA DISSECTRON Hand pieces and Sontrodes
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.