Z-2123-2011

Lap-Band Access Port Needle 10-Pack, 20 G x 51 mm (2 in.)

Name: Z-2123-2011 Lap-Band Access Port Needle 10-Pack, 20 G x 51 mm (2 in.)
Creator: Allergan
Published: 2011-03-21
License: https://open.fda.gov/license/

Allergan / initiated 2011-03-21 / Terminated / root cause: packaging

FDA source

Allergan began a recall of 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... on 2011-03-21. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2123-2011
Status: Terminated
Initiated: 2011-03-21
Posted: 2011-05-02
Terminated: 2012-04-06
Recalling firm: Allergan
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.
Product code: LTI Implant, Intragastric For Morbid Obesity
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.
Root cause tag: packaging
FDA root cause: 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
Product codes and lots: Lot Number: 9L01 N

Product code LTI

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)