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FDAJanuary 10, 2018device

PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CTB-1 Needle

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

ethicon

UPCs

10705031048829

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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