Ethicon Recalls PRONOVA Suture Needles Due to Packaging Perforation Risk
Ethicon is recalling specific PRONOVA suture needles because a packaging design issue may allow the needle to perforate the package, posing injury or infection risks.
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 no specific injuries or illnesses have been reported in the source text, fitting the High severity criteria.
Plain-English summary
Ethicon, Inc. is recalling 144 units of PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027. 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, if the perforation goes unnoticed, a breach of sterility within the packaging could lead to 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 lot codes are KJQ311 and KKE670. Healthcare professionals should stop using the affected products and contact Ethicon for further instructions.
The recalled product
- Product
- PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
- Manufacturer
- Ethicon, Inc.
- Affected units
- 144
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)
- KJQ311 KKE670
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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