Ethicon Recalls Proline Sutures Due to Packaging Perforation Risk
Ethicon is recalling 372 units of Proline Suture Blue 18" 7-0 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 372 units of PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631. 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 lot codes are LCJ948 and MCQ529. Healthcare professionals should check their inventory for these specific product codes and stop using them if the packaging is compromised.
The recalled product
- Product
- PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
- Manufacturer
- Ethicon, Inc.
- Affected units
- 372
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)
- LCJ948 MCQ529
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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