Z-1534-2018Class II

Evicel Accessory Device - 45 cm Flexible Tip (SET OF 3), Product Code EVT45. Accessory Tips for use only with...

Name: Z-1534-2018 Evicel Accessory Device - 45 cm Flexible Tip (SET OF 3), Product Code EVT45. Accessory Tips for use only with...
Creator: Ethicon, Inc.
Published: 2018-03-07
License: https://open.fda.gov/license/

Ethicon, Inc / initiated 2018-03-07 / Terminated / root cause: labeling and UDI

FDA source

Ethicon, Inc. began a recall of 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 on 2018-03-07. FDA classified it as Class II and gives the reason as "Products labeled for distribution outside the United States may have been distributed to customers in the United States". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1534-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-07
Posted: 2018-04-26
Terminated: 2019-04-30
Recalling firm: Ethicon, Inc
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.
Product code: FMF Syringe, Piston
Reason for recall: Products labeled for distribution outside the United States may have been distributed to customers in the United States.
Root cause tag: labeling and UDI
FDA root 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 [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
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.
Product codes and lots: Lot 17-0102

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1534-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1534-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-02	2018-04-26

Product code FMF

K070575Class IIEvicel Application DeviceOmrix Biopharmaceuticals , Ltd. / cleared 2007-05-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)