Ethicon Recalls PDS Plus Antibacterial Sutures Due to Incorrect Expiry Dates
Ethicon is recalling PDS Plus Antibacterial Sutures because three lots were labeled with an incorrect five-year expiry date instead of the correct two-year date.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: The recall is classified as FDA Class II, and the hazard involves a labeling error regarding expiry dates. This aligns with the rubric for moderate severity involving minor labeling errors or low-risk contamination.
Plain-English summary
Ethicon, Inc. is recalling 180 units of PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CTB-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 product was distributed in the United States, Canada, India, and Colombia.
Healthcare providers and consumers should stop using the affected suture products and contact Ethicon for further instructions or a return. The specific product code is PDPB346, GTIN is 10705031048829, and the lot number is LMM273.
The recalled product
- Product
- PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CTB-1 Needle
- Manufacturer
- Ethicon, Inc.
- Category
- Medical Device — Sutures
- Hazard
- Affected units
- 180
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: PDPB346 GTIN: 10705031048829 Product lot: LMM273
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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