Ethicon Proline Suture Recall Due to Packaging Perforation Risk
Ethicon is recalling 1,728 units of Proline suture 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 (soft tissue injury or infection) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Ethicon, Inc. is recalling 1,728 units of PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981. 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 or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional. 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 check their inventory for the specific product codes listed in the recall notice (KGJ667, KJJ690, KMH714, KPP499, LBJ528, LCJ143, LPJ095, MDH288) and stop using any affected units. Patients who have received this product should contact their healthcare provider if they have concerns about potential injury or infection.
The recalled product
- Product
- PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
- Manufacturer
- Ethicon, Inc.
- Category
- Medical Device — Sutures
- Affected units
- 1,728
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)
- KGJ667 KJJ690 KMH714 KPP499 LBJ528 LCJ143 LPJ095 MDH288
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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