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.
Reported: May 2, 2018 Initiated: March 7, 2018 #Z-1534-2018
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.
Details
- Recalling Firm
- Ethicon, Inc.
- Units Affected
- 738 devices (246 boxes of 3)
- Distribution
- 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.
- Location
- Somerville, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Ethicon, Inc.. Units affected: 738 devices (246 boxes of 3).
Why was this product recalled? ▼
Products labeled for distribution outside the United States may have been distributed to customers in the United States.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 2, 2018. Severity: Moderate. Recall number: Z-1534-2018.
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