medical MODERATE Updated 2024-11-13

Ethicon, Inc. recalls Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.

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Recalled Product

Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H

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Hazard / Issue

Complaints were received regarding needle pull-off and suture degradation. Analysis on returned product from this lot confirmed that some sutures were visually degraded in the package.

Issued by

FDA

Distribution: International distribution to the country of China.
Lot/Code Info: UDI-DI: 10705031237308 (each); 30705031237302 (box); Lot Number: QP2AJM

✅ 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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