FDA Device recall Z-1126-2015
BodyGuard 323 pump, models 100-510PXSI, 100-516PXS, 100-517PXS, 100-518PXS, 100-603XSA and 100-603XSAP
- FDA Device
- Class II
- terminated
- Published 2015-02-25
On 2015-02-25 the FDA classified a Class II recall of BodyGuard 323 pump, models 100-510PXSI, 100-516PXS, 100-517PXS, 100-518PXS, 100-603XSA and 100-603XSAP by Cme America, citing CME America is recalling the BodyGuard and BodyGuard 323 Infusion pumps due to the potential for an over delivery.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1126-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-01-16 |
| Published | 2015-02-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Cme America |
| Distribution | US |
Product
BodyGuard 323 pump, models 100-510PXSI, 100-516PXS, 100-517PXS, 100-518PXS, 100-603XSA and 100-603XSAP
Reason
CME America is recalling the BodyGuard and BodyGuard 323 Infusion pumps due to the potential for an over delivery.
Identifiers
| code_info | All product with USA36A4.4 version of software affected |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1126-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.