medical MODERATE Updated 2018-04-18

Ethicon, Inc. recalls PDS Plus Antibacterial (Polydioxanone) Suture Size 1 PDS PL

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Recalled Product

PDS Plus Antibacterial (Polydioxanone) Suture Size 1 PDS PLUS Violet 27 Single Armed OS-4 Needle

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Hazard / Issue

Three (3) lots were distributed with the incorrect expiry date on the label. The lots were labeled with an expiry date of five (5) years from date of manufacture instead of the correct expiry date of two (2) years from date of manufacture.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Product code: PDP695H GTIN: 10705031048584 Product lot: LL6590

✅ 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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