Ethicon Recalls Certain Prolene Sutures Due to Packaging Design Issue
Ethicon, Inc. is recalling 432 units of Prolene Suture 30" 8-0 Blue (D8292) because the needle may perforate the packaging, 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 no specific injuries or illnesses have been reported in the source text, fitting the High severity criteria.
Plain-English summary
Ethicon, Inc. is recalling 432 units of PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292 (Lot LLH858). 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 may cause soft tissue injury to a healthcare professional handling the product or patient infection due to a breach of sterility if the damage goes unnoticed. 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 suture products and contact Ethicon, Inc. for further instructions.
The recalled product
- Product
- PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292
- Manufacturer
- Ethicon, Inc.
- Category
- Medical Device — Sutures
- Affected units
- 432
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)
- LLH858
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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