Recall Z-2150-2015 ยท JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered
Gardner Denver Thomas Inc
THOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator, Model 1242 Product Usage: medical aspirator
| Date | Jul 20, 2015 (initiated Jun 4, 2015) |
| Status | Terminated |
| Reason | Vacuum pump may not perform to specification. |
| Root cause | Nonconforming Material/Component |
| Action | Gardner Denver Thomas sent an Important Medical Device Recall letter dated May 7, 2015 to affected distributors. The letter identified the affected products, problem and actions to be taken. For questions call your Customer Service Representative or Sales Representative or the Recall Coordinator at 920-451-6423. |
| Quantity | 370 units |
| Distribution | Internationally Distributed in the countries of :Mexico, Peru, El Salvador, Chile, Colombia, Vietnam, and Malaysia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K965059 | CPI, MAXI-VAC(6480),THOMAS INDUSTRIES, MEDI-PUMP(1240/1242/1243) Thomas Industries, Mar 4, 1997 |