Prolene Suture Blue 4x18"5/0 DA Rb-2 +plg recall: Sterility Concern
PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
Why was Prolene Suture Blue 4x18"5/0 DA Rb-2 +plg recalled?
The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
KEB378 KKJ784 MCP374
- Product
- PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
- Recalling firm
- Ethicon, Inc.
- Quantity
- 588
- Distribution
- 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, WV.
- Recall date
- July 25, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)