FDA Medical Device Recalls (openFDA)
Applied Medical Resources Corp: Applied Medical's LAP CHOLE KIT ; Model Number: K0630 The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures.
- Recall number
- Z-1511-2011
- Recalling firm
- Applied Medical Resources Corp
- Product
- Applied Medical's LAP CHOLE KIT ; Model Number: K0630 The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures.
- Status
- Terminated
- Initiated
- 2010-09-10
- Posted
- 2011-03-03
- Terminated
- 2011-03-09
- Reason
- Applied Medical is conducting a voluntary recall of specific lot numbers of the Direct Drive Laparoscopic Clip Applier, model number CA090, due to a potential defect in the jaws, possibly resulting in jaw breakage.
- Root cause
- Process design
- Action
- Applied Medical sent an URGENT: MEDICAL DEVICE RECALL letter dated September 10, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory and complete the attached Voluntary Recall Notification Confirmation Form and fax it to 949-713-8832. Customers were asked to return all affected product. Secondary consignees were notified by Applied Medical on September 16, 2010. For any questions regarding this recall call 949-713-8041.
- Quantity
- 2,843 units for all products
- Distribution
- Worldwide Distribution - USA including AL, AR, AZ, CA, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OR, PA, SC, TN, TX, VT, WA, and WI and the countries of Australia, Europe, Japan, and Kuwait.
- Lot, serial or model codes
- LOT NUMBER(S): 1122117
- 510(k) numbers
- not on file
- 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