510(k) K042696 ยท FRN Pump, Infusion
BODYGUARD INFUSION PUMP SYSTEM
| Applicant | Caesarea Medical Electronics , Ltd., Caesarea, IL |
| Decision | Substantially Equivalent, Mar 11, 2005 |
| Received | Sep 30, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042696
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 15, 2020 | CME America, LLC BodyGuard BodySet, REF: A120-160SAS Terminated |
FPA | None listed |
| Jul 15, 2020 | CME America, LLC BodyGuard Microset, REF: A120-160XPS Terminated |
FPA | None listed |
| Jul 15, 2020 | CME America, LLC BodyGuard Microset, REF: A100-163XESV Terminated |
FPA | None listed |
| Jul 15, 2020 | CME America, LLC BodyGuard Microset, REF: A100-163XES Terminated |
FPA | None listed |
| Jul 15, 2020 | CME America, LLC BodyGuard Microset, REF: A120-161XPS Terminated |
FPA | None listed |
| Jul 15, 2020 | CME America, LLC BodyGuard Microset, REF: A120-160XSFK Terminated |
FPA | None listed |
| Jul 15, 2020 | CME America, LLC BodyGuard Microset, REF: A120-112XSFK Terminated |
FPA | None listed |
| Jul 15, 2020 | CME America, LLC BodyGuard Microset, REF: A100-163XSFL Terminated |
FPA | None listed |
| Jul 15, 2020 | CME America, LLC BodyGuard Microset, REF: A120-160XYSF Terminated |
FPA | None listed |
| Jul 15, 2020 | CME America, LLC BodyGuard Microset, REF: A120-161XYB Terminated |
FPA | None listed |
| Jul 15, 2020 | CME America, LLC BodyGuard Microset, REF: A120-161XYBS Terminated |
FPA | None listed |
| Jul 15, 2020 | CME America, LLC BodyGuard Microset with Filter, REF: A100-163XESF Terminated |
FPA | None listed |
| Jul 15, 2020 | CME America, LLC BodyGuard Microset, REF: A120-161XPSV Terminated |
FPA | None listed |
| Jul 15, 2020 | CME America, LLC BodyGuard Microset, REF: A120-160X2YB Terminated |
FPA | None listed |
| Jul 15, 2020 | CME America, LLC BodyGuard Microset with Needleless Adaptor, REF: A120-003XSNY Terminated |
FPA | None listed |
| Jul 15, 2020 | CME America, LLC CMExpress Microbore Set, REF: A120-160CRV Terminated |
FPA | None listed |
| Jul 15, 2020 | CME America, LLC CMExpress Microbore Set, REF: A120-161CYF Terminated |
FPA | None listed |
| Jul 15, 2020 | CME America, LLC BodyGuard Microset w/ Non-Vented Spike Connector, REF: A100-163XEBS Terminated |
FPA | None listed |
| Jul 15, 2020 | CME America, LLC BodyGuard Microset with Filter, REF: A120-160XSFE Terminated |
FPA | None listed |
| Jul 15, 2020 | CME America, LLC BodyGuard Microset with Filter, REF: A100-164XESF Terminated |
FPA | None listed |
| Jul 15, 2020 | CME America, LLC BodyGuard Microset, REF: A100-163XE90S Terminated |
FPA | None listed |
| Jul 15, 2020 | CME America, LLC BodyGuard Microset, REF: A100-163XSL Terminated |
FPA | None listed |
| Jul 15, 2020 | CME America, LLC BodyGuard Microset, REF: A120-003XS2YV Terminated |
FPA | None listed |
| Jul 15, 2020 | CME America, LLC BodyGuard Microset, REF: A120-125XSE Terminated |
FPA | None listed |
| Jul 15, 2020 | CME America, LLC BodyGuard Microset, REF: A120-160GCFA Terminated |
FPA | None listed |
| Jul 15, 2020 | CME America, LLC CMExpress Microbore Sets, REF: A120-160CYFRV Terminated |
FPA | None listed |
| Jul 15, 2020 | CME America, LLC CMExpress Microbore Sets, REF: A120-160C2YRV Terminated |
FPA | None listed |
| Jul 15, 2020 | CME America, LLC CMExpress Microbore Sets, REF: A120-161C Terminated |
FPA | None listed |
| Jul 15, 2020 | CME America, LLC BodyGuard Microset with Male Luer Connectors, REF: A100-163XEBF Terminated |
FPA | None listed |
| Jul 15, 2020 | CME America, LLC BodyGuard set with Female Luer, REF: A120-003XSN Terminated |
FPA | None listed |
| Jul 15, 2020 | CME America, LLC BodyGuard Microset with Filter and Manual Priming Valve, REF: A120-112XSFV Terminated |
FPA | None listed |
| Jul 15, 2020 | CME America, LLC BodyGuard Microset w/ 0.2 mic filter and lower y-site with female luer, REF: A120-160XYBF Terminated |
FPA | None listed |
| Jul 15, 2020 | CME America, LLC Standard BodySet with Needleless Connectors, REF: A120-125XS Terminated |
FPA | None listed |
| Jul 15, 2020 | CME America, LLC CMExpress Microbore Set, REF: A120-160C Terminated |
FPA | None listed |
| Jul 15, 2020 | CME America, LLC CMExpress Needleless Y Site Microbore Set, REF: A120-160CYNVK Terminated |
FPA | None listed |
| Jul 15, 2020 | CME America, LLC BodyGuard Microset With Female Luer, REF: A120-160XPSN Terminated |
FPA | None listed |
| Jul 15, 2020 | CME America, LLC BodyGuard Microset w/ 0.2 mic filter and lower y-site with female luer, REF: A120-160CYFRV Terminated |
FPA | None listed |
| Mar 11, 2020 | CME America, LLC BodyGuard Microset REF A120-003XYVA, Sterile EO, Tubing: 150 in. (380 cm), Prime Vol: approx. 8ml
Product Usage: The BodyGuard Infusion Pump System is designed to transfer medication and fluids int Terminated |
FRN | None listed |
| Feb 27, 2020 | CME America LLC CMEAmerica BodyGuard Wall Charger: Lot number 2019-0364, Mode/Catalogue number 151-143XL, *+B 01151143X L0/$$72019-0364/ 16D20191101/*
Lot Number Label: BODYGUARD LOT 2019-0364 Manufacturing Date: 20 Terminated |
FRN | None listed |
| Feb 19, 2015 | CME America, LLC BodyGuard 323 pump, models
100-510PXSI, 100-516PXS, 100-517PXS, 100-518PXS,
100-603XSA and 100-603XSAP Terminated |
FRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.