Ethicon Recalls Proline Sutures Due to Packaging Perforation Risk
Ethicon is recalling 588 units of Proline Suture Blue 4x18" 5/0 due to a packaging design issue that may allow the needle to perforate the package, posing a risk of 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 criteria for a High severity score.
Plain-English summary
Ethicon, Inc. is recalling 588 units of PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879. The recall is due to a packaging design issue where the needle associated with certain suture product codes has the potential to perforate the packaging.
A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling the subject product. Additionally, a breach of sterility within the packaging, if it goes unnoticed by the healthcare professional, has the potential to cause a patient infection.
The affected products were distributed to accounts in AZ, CA, CO, FL, GA, IL, IN, KS, MA, MN, MO, NC, NE, NJ, NY, OH, OR, SC, SD, TN, TX, VA, WA, WI, and WV. The specific product codes involved are KEB378, KKJ784, and MCP374.
The recalled product
- Product
- PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
- Manufacturer
- Ethicon, Inc.
- Category
- Medical Device — Sutures
- Affected units
- 588
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)
- KEB378 KKJ784 MCP374
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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