PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CTB-1 Needle
Check against the official notice below — it lists the full affected range.
Ethicon, Inc. is recalling PDS Plus Antibacterial Suture Size 0 (violet, single armed with CTB-1 needle) because three lots were labeled with an incorrect expiry date. The affected products were labeled with an expiration date of five years from manufacture when the correct expiration date is two years from manufacture. A total of 180 units from lot LMM273 (product code PDPB346) were distributed nationwide in the United States, as well as in Canada, India, and Colombia.
The recall notice does not specify what consumers or healthcare providers should do regarding 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: 180 Lot/code info: Product code: PDPB346 GTIN: 10705031048829 Product lot: LMM273
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.