Ethicon Recalls Three Stratafix Suture Units for Internal Testing Failures
Ethicon, Inc. is recalling three units of Stratafix Spiral PDS Plus Violet sutures because they do not meet internal testing specifications.
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: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, indicating a theoretical risk or minor defect consistent with a moderate severity score.
Plain-English summary
Ethicon, Inc. is recalling three units of 1 STRATAFIX Spiral PDS Plus Violet 18" (45cm) OS-6 Needle, model SXPP1B201. The recall is identified by FDA recall number Z-1334-2020.
The product is being recalled because it does not meet certain internal testing specifications. The specific nature of the testing failure is not detailed in the source text.
The affected units are identified by Lot Number PAH360, GTIN 10705031235861, and an expiration date of 12/31/2020. The products were distributed internationally to Australia, Hong Kong, India, Japan, Korea, Singapore, and Thailand. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- 1 STRATAFIX Spiral PDS Plus Violet 18" (45cm) OS-6 Needle, SXPP1B201
- Manufacturer
- Ethicon, Inc.
- Category
- Medical Device — Sutures
- Hazard
- Affected units
- 3
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)
- GTIN: 10705031235861 Lot Number: PAH360 Expiration Date: 12/31/2020
Distribution
Distribution scope not specified by the agency.
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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