Z-1534-2018 Class II Terminated
FDA device recall Z-1534-2018 was initiated by Ethicon, Inc. on Mar 7, 2018 and is designated Class II. Reason for recall: Products labeled for distribution outside the United States may have been distributed to customers in the United States. The recall status is terminated (terminated Apr 30, 2019). Affected quantity: 738 devices (246 boxes of 3).
Recall Details
- Product Type
- Devices
- Report Date
- May 2, 2018
- Initiation Date
- Mar 7, 2018
- Termination Date
- Apr 30, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 738 devices (246 boxes of 3)
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.
Distribution Pattern
The device was distributed to the following states: AK, AL, AR, AZ, CA, CO, FL, GA, IA, IL MD, MI, MN, MO, NC, ND, NJ, NV, NY, OH, PA, TN, TX, WA, WI, and WV. The device was also distributed to Puerto Rico.
Code Information
Lot 17-0102
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1534-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026