Dec 22---Allergan recalls Lap-Band Adjustable Gastric Band SYSTEMS

Manufacturer: -See Below-

Product: Medicals

Start Date: 2010-12-22  End Date: 2011-01-22

LAP-BAND Adjustable Gastric Band System; Product codes: B-2105 (ACCSS PRT II KIT (0-10CC) US), B-2106 (ACCESS PRT II KIT (0-14CC) US), B-2210 (LP-BND SYS, 9.75, STER, US), B-2215 (LAP-BAND 9.75 W/ACC PRT II US), B-2220 (LP-BND SYS, 10.0, STER, US), B-2225 (LAP-BND 10.0,ACCESS PORT II,US), B-2255 (LAP-BAND VG W/ACS PORT II (US), B-2260 (LP-BND AP STANDARD SYS, W ACC PRT II), B-2265 (LP-BND AP LG SYS, W/ACC PRT II); The Lap-Band System is a long-term implantable device intended to induce weight loss in morbidly obese patients by limiting food consumption restrictive and satiating, rather than malabsorptive). The device is surgically implanted, using either a laparoscopic or open procedure, to create a restricted opening (stoma) and a small gastric pouch to limit food consumption and induce early satiety. The main components of the device are the silicone elastomer band, access port. and kink-resistant tubing used to connect the other two components. The inner surface of the silicone band, which is placed around the stomach, is inflatable and connected by the tubing to the access port (a remote injection site. The access port is implanted on, or attached to, the rectus muscle to permit non-surgical, percutaneous adjustments to the band and thus, the stoma diameter, using sterile saline. Recall # Z-0418-2011

CODE
All Lot Numbers for the listed Product Codes

RECALLING FIRM/MANUFACTURER
Recalling Firm: Allergan, Goleta, CA, by letter dated September 15, 2010.

Manufacturer: Allergan Costa Rica, S.A., La Aurora De He, Costa Rica. Firm initiated recall is ongoing.

REASON
The recall was initiated after Allergan received reports which have been attributed to damage to the port caused by insertion of the needle into the septum of the port at an oblique angle. Allergan issued the notice to emphasize that when performing a LAP-BAND System adjustment, failure to inject the needle perpendicular to the access port septum, as described in Directions for Use, may lead to port damage which may result in subsequent port leakage. Port leakage results in deflation of the LAP-BAND System to its widest, open position and the need for a procedure to replace the port. This is most often diagnosed through discussions between the patient and clinician, based on symptoms of reduced satiety and increased appetite. Stalling of weight loss or even weight gain may also be seen.

VOLUME OF PRODUCT IN COMMERCE
Approx. 152,000

DISTRIBUTION
Nationwide

www.totalrecallinfo.com/freerecalls.php


REALIZE BAND

FDA Classifies Previous Field Action of Ethicon Endo-Surgery's REALIZE^®  Adjustable Gastric Band As Class II Recall

Cincinnati - November 03, 2010

Obtech Medical Sàrl, a medical device manufacturer, and Ethicon Endo-Surgery (EES), today announced the U.S. Food and Drug Administration (FDA) has classified the companies' previous field action related to adjustable gastric band systems sold under the brand name REALIZE^® Adjustable Gastric Bands as a Class II recall, as expected.

The voluntary recall, initiated on October 11, 2010 involves existing inventory only. Healthcare facilities were notified to immediately discontinue use of the device and return all unused REALIZE^® Bands to EES. Since then, customers have been receiving an enhanced product, recently approved by the FDA, to replace the recalled inventory and for all new orders. There is no action required for patients who already have received these gastric bands, and removal (explantation) of the gastric band is not required.

EES initiated the voluntary worldwide recall of existing inventory of adjustable gastric band systems sold under the brand name REALIZE^® Adjustable Gastric Bands due to reports of the potential for the Tubing Strain Relief, a small (2 centimeter) flexible sheath on the band’s Injection Port, to slide out of its intended position. Movement of the Tubing Strain Relief is highly unlikely to cause any serious injury or adverse health consequences and it rarely affects the band’s function. In the extremely rare instance (1 in 10,000) when tube kinking occurs at the Injection Port, the physician might be unable to adjust fluid volume within the gastric band, which may require additional surgery to correct. In most instances, this procedure can be performed under local anesthesia and in an outpatient setting. There have been no cases of gastric band removal due to the Strain Relief sliding out of position.

Patient health and safety is our utmost concern. EES identified the Tubing Strain Relief issue through its continuous quality monitoring program. With the full knowledge of the FDA, healthcare facilities were notified of the recall by official letter beginning October 11, 2010, and then by subsequent communications from EES sales representatives. The initial letter included detailed recall instructions, including the specific product codes and lot numbers affected. EES also has provided customers and third-party advocacy organizations with information for patients on the recall. Regulatory authorities worldwide also have been informed.

If surgeons or patients have any additional questions about the REALIZE^® Band recall, they may call our Customer Support Center at 1-866-REALIZE (1-866-732-5493) between 7:30 am and 6:30 p.m. Eastern Daylight Time, Monday through Friday.

For media inquiries, please contact:
Bridgett Golden
Manager, Corporate Communications
513-337-7387

About the REALIZE^® Adjustable Gastric Band
The REALIZE^® Adjustable Gastric Band is used in one type of weight-loss surgery. It contains two main components: the first is a fluid-filled balloon that is placed around the stomach; the second is an injection port to adjust the degree of fluid in the band. Thin flexible tubing connects these two main components. The recall involves an ancillary component called the Tubing Strain Relief.