Ethicon Recalls Proline Sutures Due to Packaging Perforation Risk
Ethicon is recalling specific Proline sutures 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 no specific injuries or illnesses have been reported in the source text, fitting the High severity criteria.
Plain-English summary
Ethicon, Inc. is recalling 48 units of PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662 (Lot MBJ454). The recall is due to a packaging design issue where the needle associated with the suture has the potential to perforate the packaging.
A perforated package poses a risk of soft tissue injury to healthcare professionals handling the product. Additionally, if the breach in sterility goes unnoticed, it could lead to 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.
Healthcare professionals should stop using the affected sutures and contact Ethicon for instructions on how to return the product.
The recalled product
- Product
- PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
- Manufacturer
- Ethicon, Inc.
- Category
- Medical Device — Sutures
- Affected units
- 48
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)
- MBJ454
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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