Reported Jul 24, 2024 · Ongoing
SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1961
Ethicon Sarl, a Johnson & Johnson Company
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ethicon Sarl, a Johnson & Johnson Company · rue du Puits-Godet 20 · Neuchatel · N/A
Is this the product you have?
- SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM)
- Product Number1961
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Barcodes Product as published 1961— — 1070503100311820705031003115UDI/DI: 10705031003118 (primary), 20705031003115 (box of 10) — Lot numbers: TFB9151, TEB6531, TFB8781, TEB6861, TEB6511, SKE2201, SKE2101, TDB5981, SLE4411, TEB7821, TGB9291, SBB2291, TEB6411, TEB7071, TBB2481, TBB2491, TCB4081, TCB3751, TCB3781, TEB7211, TEB6871, TEB7601, TEB6521, TCB3351, SJE0361, TCB4071, TCB4481, TCB2931, TFB8381, TGB9801, TBB1511, SJE0241, SDB5001, RPE3591, RPE3181, RME2541, TBB1661, TCB4061, TCB4471, TCB4051, SKE2111, SKE1811, SKE1791, SJB9871, SJE0231, SHB9841, TJE1191, TDB5991, TGB9301, TDB5611, TDB5621, TFB8361, SKE1781, SKE1801, TFB8001, TFB8371, TJE1201, TCB3341, TDB5631, TDB5151, TDB6001 - Amount recalled
- 450,793 units (65,950 US, 384,843 OUS)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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