Device product
BodyGuard 323 pump, models 100-510PXSI, 100-516PXS, 100-517PXS, 100-518PXS, 100-603XSA and 100-603XSAP
Z-1126-2015
Product summary
- Firm
- CME America, LLC
- Event
- Event 70294
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,186
- Official record key
device-enforcement:Z-1126-2015
Official wording
Reason: CME America is recalling the BodyGuard and BodyGuard 323 Infusion pumps due to the potential for an over delivery.
Code information: All product with USA36A4.4 version of software affected
Distribution pattern: Worldwide Distribution - Nationwide Distribution and VA/military/govt consignees and the country of Canada.
Derived failure modes
-
Unknown
CME America is recalling the BodyGuard and BodyGuard 323 Infusion pumps due to the potential for an over delivery.