Recall Z-0418-2011 ยท LTI Implant, Intragastric For Morbid Obesity
Allergan
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 SY
| Date | Nov 18, 2010 (initiated Sep 16, 2010) |
| Status | Terminated |
| Reason | In 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, resulting in subsequent port leakage. Leakage results in deflation of the LAP-BAND to its widest, open position requiring a procedure to replace the port. The patient may have symptoms of reduced satiety and increased appetite. Stalling |
| Root cause | Pending |
| Action | Allergan sent an URGENT FIELD CORRECTIVE ACTION letter dated September 15, 2010, to all affected customers. The recall communication was initiated on 09/16/2010 when the firm begin forwarding Customer letters with attached current Directions for Use distributed via Federal Express, with tracking verification provided by Federal Express, to the direct consignees. The Customer letters informed consignees of the products affected, description of the Issue, clinical implications and firm recommendations. Customers were instructed to follow the Directions for Use for inserting the needle. Cust |
| Quantity | Approx. 152,000 |
| Distribution | Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, AND WY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.