Z-0151-06

The Applied GelPort Hand Access Device consists of a GelSeal Cap, Wound retractor (base). Standard Wound...

Name: Z-0151-06 The Applied GelPort Hand Access Device consists of a GelSeal Cap, Wound retractor (base). Standard Wound...
Creator: Applied Medical Resources Corp
Published: 2005-10-17
License: https://open.fda.gov/license/

Applied Medical Resources Corp / initiated 2005-10-17 / Terminated / root cause: manufacturing process

FDA source

Applied Medical Resources Corp began a recall of The Applied GelPort Hand Access Device consists of a GelSeal Cap, Wound retractor (base). Standard Wound Protecting Sheath, Long Wound Protecting Sheath... on 2005-10-17. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0151-06
Status: Terminated
Initiated: 2005-10-17
Posted: 2005-11-16
Terminated: 2008-04-24
Recalling firm: Applied Medical Resources Corp
Product: 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.
Product code: GCJ Laparoscope, General & Plastic Surgery
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.
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 117 Units
Distribution: Nationwide
Product codes and lots: Lot Number / Expiration Date:1001381/2008-08 UPC Codes:C8004 +H699C80040K

Product code GCJ

K003871Class IILaparoscopic Hand PortApplied Medical Resources Corp. / cleared 2001-05-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)