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.
FDA Recall Z-2123-2011 · Posted 2011-05-02
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Recalling FirmAllergan
Recall StatusTerminated
Product CodeLTI
Date Initiated2011-03-21
Date Terminated2012-04-06
Product Quantity1878 x 10-packs
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.
Firm 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.
Root Cause
Pending
Distribution Pattern
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
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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