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.
FDA Recall Z-1534-2018 · Posted None
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Recalling FirmEthicon, Inc.
Recall StatusTerminated
Product CodeFMF
Date Initiated2018-03-07
Date Terminated2019-04-30
Product Quantity738 devices (246 boxes of 3)
Reason for Recall
Products labeled for distribution outside the United States may have been distributed to customers in the United States.
Firm 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 [email protected] 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
Root Cause
Other
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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