ETHIBOND EXCEL¿ Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1 Product Code: X425H Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures
Reported: June 26, 2019 Initiated: April 19, 2019 #Z-1841-2019
Product Description
ETHIBOND EXCEL¿ Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1 Product Code: X425H Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures
Reason for Recall
Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot
Details
- Recalling Firm
- Ethicon, Inc.
- Units Affected
- 1296 eaches
- Distribution
- Worldwide - US Nationwide Distribution - IA, NJ, RI, TX, WV Foreign: Canada
- Location
- Somerville, NJ
Frequently Asked Questions
What product was recalled? ▼
ETHIBOND EXCEL¿ Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1 Product Code: X425H Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures. Recalled by Ethicon, Inc.. Units affected: 1296 eaches.
Why was this product recalled? ▼
Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 26, 2019. Severity: Moderate. Recall number: Z-1841-2019.
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