Class 2 Device Recall Evicel Accessory Device

• Date Initiated by Firm: March 07, 2018
• Create Date: April 26, 2018
• Recall Status: Terminated on April 30, 2019
• Recall Number: Z-1534-2018
• Recall Event ID: 79668
• 510(K)Number: K070575
• Product Classification: Syringe, piston - Product Code FMF
• 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.
• Code Information: Lot 17-0102
• Recalling Firm/ Manufacturer: Ethicon, Inc.; Us Highway 22 West; Somerville NJ 08876
• For Additional Information Contact: Tom Morris; 513-337-3419
• Manufacturer Reason for Recall: Products labeled for distribution outside the United States may have been distributed to customers in the United States.
• FDA Determined Cause: Other
• Action: Letters distributed on 3/7/18 to hospitals instructed them to: 1. Examine your inventory immediately to determine if you have the product lot subject to this recall (removal) on hand and quarantine such product(s). 2. Remove the product lot subject to this recall (removal) and communicate the issue to all relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. If any of the devices subject to this recall (removal) have been forwarded to another facility, please contact that facility to arrange return. 3. Complete the Business Reply Form (BRF) (Attachment 2) confirming receipt of this notice and fax or email it to Stericycle at 1-877-473-7068 or Ethicon4528@stericycle.com within three (3) businessdays. Please return the BRF even if you do not have the product lot subject to this recall(removal). 4. Customers are required to return all unused EVICEL¿ 45 CM Flexible (Accessory) Tip devices for the lot subject to this recall (Lot 17-0102 Code EVT45) that are in their inventory immediately. Only unused EVICEL¿ 45 CM Flexible (Accessory) Tip devices for the lot subject to this recall (removal) returned by June 30, 2018 will be eligible for replacement. Any unused EVICEL¿ 45 CM Flexible (Accessory) Tip devices for the lot subject to this recall (removal) returned after June 30, 2018 will not be eligible for replacement. 5. To return unused EVICEL¿ 45 CM Flexible (Accessory) Tip devices for the lot subject to this recall (removal), photocopy the completed BRF, place it in the box with the subject product(s), and affix the pre-paid authorized shipping label included with this recall (removal) notification letter. Ethicon will pay for the shipping charges only if the authorized label is used. Extra shipping labels may be obtained by calling Stericycle at 1-877-597-9582 and referencing Event 4528. Your JJHCS number and mailing address have been pre-populated on the BRF. Distributors were instructed to: 1. E
• Quantity in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FMF and Original Applicant = OMRIX BIOPHARMACEUTICALS LTD.