FDA Device recall Z-2906-2016
CUSA Dissectron Fingertip Laparoscopic Cannula, REF F75221, Sterile EO, Rx only, packaged in a Tyvek pouch and secondary packaged in Tyvek…
- FDA Device
- Class II
- terminated
- Published 2016-10-12
On 2016-10-12 the FDA classified a Class II recall of CUSA Dissectron Fingertip Laparoscopic Cannula, REF F75221, Sterile EO, Rx only, packaged in a Tyvek pouch and secondary packaged in Tyvek… by Integra Lifesciences, citing during final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2906-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-08-23 |
| Published | 2016-10-12 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Integra Lifesciences |
| Distribution | US |
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.
Identifiers
| code_info | Catalog Number F75221, Lot #0195486 with expiry 04/2021 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2906-2016%22
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