SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1961
Reported: July 24, 2024 Initiated: June 11, 2024 #Z-2406-2024
Product Description
SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1961
Reason for Recall
Some foil pouches were found torn open, impacting the sterile barrier which was traced to a specific machine used during product packaging.
Details
- Recalling Firm
- Ethicon Sarl, a Johnson & Johnson Company
- Units Affected
- 450,793 units (65,950 US, 384,843 OUS)
- Distribution
- Worldwide distribution - US Nationwide and the countries of India and Japan.
- Location
- Neuchatel
Frequently Asked Questions
What product was recalled? ▼
SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1961. Recalled by Ethicon Sarl, a Johnson & Johnson Company. Units affected: 450,793 units (65,950 US, 384,843 OUS).
Why was this product recalled? ▼
Some foil pouches were found torn open, impacting the sterile barrier which was traced to a specific machine used during product packaging.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 24, 2024. Severity: Moderate. Recall number: Z-2406-2024.
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