Recall Z-1534-2018— Ethicon, Inc.
Class II · Terminated
Class II FDA medical device recall by Ethicon, Inc., initiated 2018-03-07, terminated 2019-04-30. It names one FDA 510(k) clearance: K070575. Product: Evicel Accessory Device - 45 cm Flexible Tip (SET OF 3), Product Code EVT45. Accessory Tips for use only with EVICEL Fibrin Sealant (Human) Application Device.. Reason: Products labeled for distribution outside the United States may have been distributed to customers in the United States..
- Recalling firm
- Ethicon, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-03-07
- Terminated
- 2019-04-30
- Firm location
- Somerville, 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
Evicel Accessory Device - 45 cm Flexible Tip (SET OF 3), Product Code EVT45. Accessory Tips for use only with EVICEL Fibrin Sealant (Human) Application Device.
Reason for recall
Products labeled for distribution outside the United States may have been distributed to customers in the United States.
Data sourced from openFDA. This site is unofficial and independent of the FDA.