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FDA (Device enforcement)Recalled 2018-01-10closedclass ii

Ethicon, Inc.: PDS Plus Antibacterial (Polydioxanone) Suture Size 1 PDS PLUS Violet 27 Single Armed OS-4 Needle

Is my product affected?

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

  • UPC 10705031048584

Check against the official notice below — it lists the full affected range.

What happened

Ethicon, Inc. is recalling PDS Plus Antibacterial Suture Size 1 in violet color with an OS-4 needle due to incorrect expiry dates printed on product labels. Three affected lots were labeled with an expiration date of five years from manufacture instead of the correct two-year expiration date. A total of 72 units were distributed across the United States, Canada, India, and Colombia under product lot LL6590 and product code PDP695H.

The recall record does not specify a remedy or course of action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

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.

Details from the source

Reason for recall: 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. Distribution: Distribution US Nationwide, Canada, India, and Colombia. Quantity: 72 Lot/code info: Product code: PDP695H GTIN: 10705031048584 Product lot: LL6590

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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