Recall Z-2149-2024— Ethicon, Inc.

Name: FDA recall Z-2149-2024
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: K201996. Product: MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated. PRODUCT CODE: MCP266H13 MCP3200H16 MCP3212H16 MCP3213H16 MCP340H13 MCP345H13 MCP416H14 MCP417H14 MCP426H13 MCP427H13 MCP4423H16 MCP4424H14 MCP442H14 MCP496H16 MCP497H16 MCP604H13 MCP936H13 MCP945H14 MCPB346H13. 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

K201996 — Monocryl Plus Antibacterial SutureETHICON, Inc.·cleared 2020-12-21

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

MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated. PRODUCT CODE: MCP266H13 MCP3200H16 MCP3212H16 MCP3213H16 MCP340H13 MCP345H13 MCP416H14 MCP417H14 MCP426H13 MCP427H13 MCP4423H16 MCP4424H14 MCP442H14 MCP496H16 MCP497H16 MCP604H13 MCP936H13 MCP945H14 MCPB346H13

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.