medical MODERATE Updated 2024-07-24

Ethicon Sarl, a Johnson & Johnson Company recalls SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 196

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Recalled Product

SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1961

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Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Product Number: 1961; UDI/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;

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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