Ethicon Recalls Pronova Suture Due to Packaging Perforation Risk
Ethicon is recalling 516 units of Pronova Suture Blue because the needle may perforate the packaging, posing a risk of soft tissue injury or infection.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (potential soft tissue injury or infection) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Ethicon, Inc. is recalling 516 units of PRONOVA SUTURE BLUE 122CM M1.5, D10189. The recall involves specific product codes KDQ147, KEJ159, and KGH788. These products were distributed to accounts in Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Massachusetts, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New York, Ohio, Oregon, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin, and West Virginia.
The recall is due to a packaging design issue where the needle associated with the suture has the potential to perforate the packaging. If the package is perforated and the breach goes unnoticed, it could cause a soft tissue injury to a healthcare professional handling the product or lead to a patient infection due to a breach of sterility.
Healthcare professionals should check their inventory for the affected product codes and stop using any units that may be compromised. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- PRONOVA SUTURE BLUE 122CM M1.5, D10189
- Manufacturer
- Ethicon, Inc.
- Category
- Medical Device — Sutures
- Affected units
- 516
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)
- KDQ147 KEJ159 KGH788
Distribution
Part of a larger recall action
This product is one of 19 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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