Ethicon Recalls Proline Sutures Due to Packaging Perforation Risk
Ethicon is recalling specific Proline sutures because a packaging design issue allows needles to perforate the package, posing injury and 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 and infection) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Ethicon, Inc. is recalling 456 units of PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881. 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 product. Additionally, a breach of sterility within the packaging could lead to a patient infection if the perforation goes unnoticed by the healthcare professional.
The affected units 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 associated with this recall are LDP667 and LPH861.
The recalled product
- Product
- PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
- Manufacturer
- Ethicon, Inc.
- Category
- Medical Device — Sutures
- Affected units
- 456
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)
- LDP667 LPH861
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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