Ethicon, Inc.: PROCEED Surgical Mesh Hernia Mesh Oval, 15 cm x 20 cm

Is my product affected?

PROCEED Surgical Mesh Hernia Mesh Oval, 15 cm x 20 cm

• UPC 10705031047716

Check against the official notice below — it lists the full affected range.

What happened

Ethicon, Inc. is recalling PROCEED Surgical Mesh Hernia Mesh Oval, 15 cm x 20 cm, because a customer found a hair inside the primary packaging of a single unit. Since this is a sterile device, the presence of a foreign object in the packaging presents a potential contamination hazard. The affected lot number is PHG118 (Product Code PCDG1, expiration date 07/31/2021), with 295 units distributed to 27 countries worldwide, though the recall is limited to 15 units distributed in South Korea based on that country's regulatory requirements.

The record does not specify what actions affected consumers should take regarding this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

The firm is recalling the PROCEED Surgical Mesh device, because it is a sterile device, and a customer found a hair inside of the primary packaging of a single unit.

Details from the source

Reason for recall: The firm is recalling the PROCEED Surgical Mesh device, because it is a sterile device, and a customer found a hair inside of the primary packaging of a single unit. Distribution: The impacted lot (295 units) was distributed to 27 countries worldwide excluding the US. However, the firm is only recalling the 15 units that were distributed in South Korea due to South Korea's Ministry of Food and Drug Safety (MFDS) requirements. Quantity: 295 units distributed. Only 15 units are being recalled. Lot/code info: Product Code - PCDG1 Product Lot - PHG118 GTIN Code - 10705031047716 Expiration Date: 07/31/2021

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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