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SURGICEL FIBRILLAR recallZ-2407-2024 · Ethicon Sarl, a Johnson & Johnson Company · initiated Jun 11, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Ethicon Sarl, a Johnson & Johnson Company or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Some foil pouches were found torn open, impacting the sterile barrier which was traced to a specific machine used during product packaging.

FDA root cause category: Process control

What the company is doing

On Jun 11, 2024, URGENT: MEDICAL DEVICE RECALL (REMOVAL) letters were sent to consignees. ACTION REQUIRED: 1. Examine your inventory immediately to determine if you have the lot numbers from the product codes listed in Attachment 1 on hand and quarantine such product(s). If you have product subject to this recall, please maintain a copy of this notice with the quarantined product and keep a copy for your records. 2. Communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. If any product subject to this recall has been forwarded to another facility, contact that facility to arrange return. Please consider including a copy of this recall letter when communicating. 3. Complete the Business Reply Form (BRF) (Attachment 3) confirming receipt of this notice and fax or email to Sedgwick at 855-207-8799 or [email protected] within three (3) business days. Please return the BRF even if you do not have product subject to this recall. 4. Customers are required to return unused SURGICEL" FIBRILLAR" Absorbable Hemostat subject to this recall that are in inventory immediately. Credit will be issued to customers who ordered directly from Ethicon. Credit or replacement product as appropriate will be provided to customers who ordered through a distributor. To receive credit or replacement product, customers must return product subject to this recall no later than September 30, 2024. Any non-affected product and any product returned after the date specified will not be eligible for credit or replacement product. 5. To return product subject to this recall, photocopy the completed BRF, place it in the box with the product, and affix the pre-paid authorized shipping label included with the recall notification letter. Ethicon will pay for the shipping charges only if the authorized label is used. Extra shipping labels may be obtained by calling Sedgwick at 855-620-5696. Your account number and ma

Recall details

Recall number
Z-2407-2024
Status
Open, Classified
Initiated by the company
Jun 11, 2024
Posted by the FDA
Jul 17, 2024
Recalling firm
Ethicon Sarl, a Johnson & Johnson Company
Quantity
39,010 units (All US)
Product code
LMG
Distribution
Worldwide distribution - US Nationwide and the countries of India and Japan.

Product description

SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1963

Code information (models, lots, serial numbers)

Product Number: 1963; UDI/DI: 10705031003132 (primary), 20705031003139 (box of 10); Lot numbers:

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 94831).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page