PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
Reported: July 25, 2018 Initiated: May 7, 2018 #Z-2458-2018
Product Description
PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
Reason for Recall
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.
Details
- Recalling Firm
- Ethicon, Inc.
- Units Affected
- 456
- 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.
- Location
- Somerville, NJ
Frequently Asked Questions
What product was recalled? ▼
PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881. Recalled by Ethicon, Inc.. Units affected: 456.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 25, 2018. Severity: Moderate. Recall number: Z-2458-2018.
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