Recall Z-2144-2024— Ethicon, Inc.

Name: FDA recall Z-2144-2024
Creator: U.S. Food and Drug Administration
Published: 2024-05-10

Class II · Ongoing

Class II FDA medical device recall by Ethicon, Inc., initiated 2024-05-10. It names one FDA 510(k) clearance: K022269. Product: 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: Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection ..

Recalling firm: Ethicon, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2024-05-10
Firm location: Raritan, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K022269 — COATED VICRYL* (POLYGLACTIN 910) SUTUREETHICON, Inc.·cleared 2002-09-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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 .

Data sourced from openFDA. This site is unofficial and independent of the FDA.