Recall Z-1126-2015 ยท FRN Pump, Infusion
CME America, LLC
BodyGuard 323 pump, models 100-510PXSI, 100-516PXS, 100-517PXS, 100-518PXS, 100-603XSA and 100-603XSAP
| Date | Feb 19, 2015 (initiated Jan 16, 2015) |
| Status | Terminated |
| Reason | CME America is recalling the BodyGuard and BodyGuard 323 Infusion pumps due to the potential for an over delivery. |
| Root cause | Software design |
| Action | CME America sent an "Urgent Medical Device Recall" letter dated January 16, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Required Action for Users: To date there have been no reports of adverse events or serious injury. However, there is the potential for serious injury or death. CME America recommends that you DO NOT use the BodyGuard 323 pump for PCA infusion. If your devices are currently in use, be sure that the programmed parameters DO NOT involve a patient controlled bolus dose less than 0.1 miln volu |
| Quantity | 3,186 |
| Distribution | Worldwide Distribution - Nationwide Distribution and VA/military/govt consignees and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042696 | BODYGUARD INFUSION PUMP SYSTEM Caesarea Medical Electronics , Ltd., Mar 11, 2005 |