VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissues. PRODUCT CODE: J214H J218H J258H J268H J269H J327H J344H J345H J370H J416H J417H J426H J427H J458H J493H J603H J699H J936H J978H
Reported: June 26, 2024 Initiated: May 10, 2024 #Z-2144-2024
Product Description
VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissues. PRODUCT CODE: J214H J218H J258H J268H J269H J327H J344H J345H J370H J416H J417H J426H J427H J458H J493H J603H J699H J936H J978H
Reason for Recall
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Details
- Recalling Firm
- Ethicon, Inc.
- Units Affected
- 341532 units
- Distribution
- Worldwide distribution - US Nationwide including PR and the countries of AR, AU, AU, BE, BR, CA, CA, CL, CN, CO, CR, EC, IL, JP, JP, KW, MX, NZ, PA, PR, PR, SA, SG, UY, ZA.
- Location
- Raritan, NJ
Frequently Asked Questions
What product was recalled? ▼
VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissues. PRODUCT CODE: J214H J218H J258H J268H J269H J327H J344H J345H J370H J416H J417H J426H J427H J458H J493H J603H J699H J936H J978H. Recalled by Ethicon, Inc.. Units affected: 341532 units.
Why was this product recalled? ▼
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 26, 2024. Severity: Moderate. Recall number: Z-2144-2024.
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