Recall Z-2407-2024— Ethicon Sarl, a Johnson & Johnson Company
Class II · Ongoing
Class II FDA medical device recall by Ethicon Sarl, a Johnson & Johnson Company, initiated 2024-06-11. FDA's recall record names no specific 510(k) clearance for this event. Product: SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1963. Reason: Some foil pouches were found torn open, impacting the sterile barrier which was traced to a specific machine used during product packaging..
- Recalling firm
- Ethicon Sarl, a Johnson & Johnson Company
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-06-11
- Firm location
- Neuchatel, Switzerland
Product description
SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1963
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.