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Terminated

The Applied GelPort Hand Access Device consists of a GelSeal Cap, Wound retractor (base). Standard Wound Protecting Sheath, Long Wound Protecting Sheath. Impervious Sleeve, Skin Marker. Sterile Lubricant, and Incision Template.

FDA Recall Z-0151-06 · Posted 2005-11-16

Recalling FirmApplied Medical Resources Corp
Recall StatusTerminated
Product CodeGCJ
Date Initiated2005-10-17
Date Terminated2008-04-24
Product Quantity117 Units

Reason for Recall

The Applied GelPort Laparoscopic Hand Access Device, Model C8004. product is being recalled due to an incorrect component. The incorrect Wound Retractor base was packaged with the kit.

Firm Action

The recall was initiated on October 14,2005. Applied Medical will contact all customers involved in the recall via overnight FEDEX / UPS. A follow-up communication concerning the recall notification letter will be sent to each of the customers who have not responded with 30 days.Applied is requesting product lot listed in the notification be returned to Applied Medical. All product involved in the recall will be destroyed.

Root Cause

Process control

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K003871LAPAROSCOPIC HAND PORTApplied Medical Resources Corp. · 2001-05-31

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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