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E-PACK

Ethicon Inc. · Model 9952E · UDI-DI 20705031243733

GANGAMGAQGAWFZPLDFFTL Prescription
7
510(k) clearances
5,585
Adverse events (8 deaths)
2
Recalls
28
Facilities

Description

E-Pack Procedure Kit

Recalls

DateFirmReason
2024-10-08ETHICON, INC.Due a component mix-up in manufacturing, the affected products may contain incorrect needle type/size and suture length.
2024-05-10Ethicon, Inc.Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.