Ethicon Recalls PDS Plus Antibacterial Sutures Due to Incorrect Expiry Dates
Ethicon, Inc. is recalling specific lots of PDS Plus Antibacterial Sutures because they were labeled with an incorrect expiry date of five years instead of two.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a labeling error (incorrect expiry date) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Ethicon, Inc. is recalling 7,020 units of PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CT-1 Needle. The recall involves three lots that were distributed with incorrect expiry dates on the labels.
The affected lots were labeled with an expiry date of five years from the date of manufacture, whereas the correct expiry date is two years from the date of manufacture. The specific product code is PDP346H, GTIN is 10705031048126, and the lot number is LL6459.
These products were distributed in the United States, Canada, India, and Colombia. The source text does not specify instructions for consumers or healthcare providers regarding the handling of these recalled items.
The recalled product
- Product
- PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CT-1 Needle
- Manufacturer
- Ethicon, Inc.
- Category
- Medical Device — Sutures
- Hazard
- Affected units
- 7,020
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Product code: PDP346H GTIN: 10705031048126 Product lot: LL6459
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Ethicon, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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