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U.S. Department of Health and Human Services

Class 2 Device Recall LAPBAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM

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  Class 2 Device Recall LAPBAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM see related information
Date Initiated by Firm March 21, 2011
Date Posted May 02, 2011
Recall Status1 Terminated 3 on April 06, 2012
Recall Number Z-2123-2011
Recall Event ID 58574
PMA Number P000008 
Product Classification Implant, intragastric for morbid obesity - Product Code LTI
Product Lap-Band Access Port Needle 10-Pack, 20 G x 51 mm (2 in.), Product Code: 8-20302-10, Lot Number: 9L01N
20 gauge, 51 mm (2 in.) length non-coring deflected tip (Huber) needle, used with the LAP-BAND System for band adjustment.
Code Information Lot Number: 9L01 N
Recalling Firm/
Manufacturer		 Allergan
71 S Los Carneros Rd
Goleta CA 93117-5506
For Additional Information Contact
805-683-6761
Manufacturer Reason
for Recall		 The recall was initiated because Allergan has determined that a number of Access Port Needle pouches from one specific lot number may have small gaps in a pouch seal. Consequently the product may no longer be sterile.
FDA Determined
Cause 2		 Pending
Action Allegan sent an Urgent Medical Device Recall letter dated March 21, 2011, to all affected customers. Allergan requested that upon receipt of letter, that the customer check their existing inventory of product for affected lot. Customers were requested to complete Business Reply Card, stating quantity of inventory of affected lot, if any, and return to Allergan Medical. Customer with remaining inventory were instructed to contact Allergan Medical Product Support at 1-800-624-4261, x5972 or 1-805-961-5972 for return and immediate replacement. . Customers will be issued credit for returned product. For questions regarding this recall call 805-319-0589.
Quantity in Commerce 1878 x 10-packs
Distribution Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, MN, NV, NY, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV and the countries of Australia, Canada, Germany, Great Britian, and the Netherlands
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = LTI and Original Applicant = ReShape Lifesciences, Inc.
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