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Class IIOngoingZ-0971-2025

CareFusion 303, Inc. recalls BD Pyxis MedStation ES (Med ES Main)

CareFusion 303, Inc.San Diego, CA, United StatesReported Jan 29, 2025 · 1 year ago
Legal News Analyst ·

Reason for recall

Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified: Situation 1: Door Latch Failure, Situation 2: Cable Ribbon Damage, Situation 3: Magnet Falling Out,

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • BD Pyxis MedStation ES (Med ES Main), REF323
    400 affected lots
    1243989712440725124409741244097512441103124413331244143212447684
    +392 more1245124712451619124554921245549312455498124557931245697012463612124694701246947112469488124708421247402612476547124832011248320312483393124834021248673712499043124996161249961712499618124998381250193612502072125020731250207412502075125020761250207712502078125020791250208012504784125059821250725712507258125074111250830312510196125111661251116712511168125111691251117012511171125111721251117312511174125119331251193412511935125142651251426612514267125153551251535612515357125153581251536012515364125153661251909812522942125244811252793012528709125287101253009012531297125312981253135212531353125313541253141412531415125314161253141712531418125314201253142112531422125314231254019412540196125402671254026812540269125463261254675512554583125611391256869712569170125707451257074612570748125707491257075012570753125808421258268712585183125851841258730212587564125884211258961812589657125896581258965912589685125901191259095612591330125932591259382712593828125938291259388212594025125953261259640412597474125974751259747712597478125974791259748912597491125974921259749312598838125990611259906212599063125990641259906512599066125990671259906912599070125991351259913612599137125991381259913912599140125991411259957012599571125999701259997112600268126004351260046712600468126004691260068712600689126006901260069112600880126021401260235712602358126023591260236012602361126023721260237412602731126037501260375112603752126037581260375912603760126058931260598512606524126081391260863112611808126118161261192612612390126123921261239312612394126125671261266912613847126138491261538312615385126153861261623912617122126213321262133312621334126222761262296812622969126229701262297112624466126262031262620412626206126262121262788912627994126279951262799612628692126286931262869512628696126286971262869812628701126287101262871112629602126296031262960412629627126303891263089012632182126321951263241812632419126333121263480112634802126370471263704812637961126379621263796312638017126380181263803112638404126384051263840712638409126395381263989312639894126398951263989612639897126420451264204612642047126420481264204912647152126500911265067912650774126514251265203912652625126531471265360212655694126563191265632012656321126563221265669212656693126568121265710112657819126578201265782112657822126579401265818512658188126592451265951512661587126615881266264712662648126629211266292212662923126652241266535612665357126653581266535912665360126653611266619912666200126689311267136712676113126761161267611712676118126786891267869312679653126808391268085412681469126815691268181512681865126831061268387412683877126839041268508512685086126850871268508812685089126850901268509112685137126863271268722912688452126884541268846412690063126901521269015312690183126901841269018512693218126935471269386812693869126938701269387512693928126939331269454912694550126945511269455512694556126945571269455812695277126952821269528312695284126952931269576412695765126957661269576712695769126957701269591612696505126965061269650712696508126967481269674912696750126967591269676312696764126967651269680012697335126973361269733712697339126973401269734112697585126976591269766012697996

What the firm is doing

BD issued an Urgent Medical Device Product Advisory to its consignees on 02/14/2023 via letter. The notice explained the problems with the device, health hazards, and requested the following actions be taken: "1. Customers may continue to use these devices as intended and should file a complaint via the Customer Portal at https://www.bd.com/self-service or call BD Support at 1-800-727-6102, should you experience drawer or door failures. 2. If you experience delays in access to medication due to a drawer or door failure, ensure backup procedures (which may include but may not necessarily be limited to keys, emergency medication supplies, alternate devices in proximity, etc.) are in place and staff have all been properly trained on them. 3. Please promptly complete and return the enclosed Customer Response Form to acknowledge receipt of this notification and that you understand the information provided in this letter. 4. If you have specific questions about this letter, please contact 1-866-583-8783." The firm issued a second notice on 01/09/2024 with the same information.

DistributionShow details

Worldwide

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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