FDA Medical Device Recalls (openFDA)
Applied Medical Resources Corp: 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.
- Recall number
- Z-0151-06
- 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.
- Status
- Terminated
- Initiated
- 2005-10-17
- Posted
- 2005-11-16
- Terminated
- 2008-04-24
- Reason
- 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
- 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
- 117 Units
- Distribution
- Nationwide
- Lot, serial or model codes
- Lot Number / Expiration Date:1001381/2008-08 UPC Codes:C8004 +H699C80040K
- 510(k) numbers
- ["K003871"]
- PMA numbers
- not on file
- Product code
- GCJ
- Firm FEI
- 2027111
- Firm city
- Rancho Santa Margarita
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28