PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CT-1 Needle
Check against the official notice below — it lists the full affected range.
Ethicon, Inc. is recalling PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CT-1 Needle from three lots that were labeled with incorrect expiry dates. The affected sutures were labeled with an expiry date of five years from manufacture when the correct expiry date should have been two years from manufacture. A total of 7,020 units were distributed across the United States, Canada, India, and Colombia. The affected product code is PDP346H with GTIN 10705031048126, and the affected lot is LL6459.
The recall notice does not specify a remedy for consumers who have obtained this product.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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: 7020 Lot/code info: Product code: PDP346H GTIN: 10705031048126 Product lot: LL6459
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.