Smiths Medical ASD Inc. recalls Medfusion Model 3500 and 4000 Syringe Infusion Pumps and Medfusion 3010 and 3010A Syringe Infusion Pumps serviced during the same time…
There have been intermittent issues with Supercap POST (power on self-test) and Backup Audible Alarm error codes outside of the pump warranty period. These alarms occur at start up when the pump goes through the…
Read the official notice →- Date
- 2022-02-23
- Country
- United States
- Brand
- Smiths Medical ASD
- Product
- Medfusion Model 3500 and 4000 Syringe Infusion Pumps and Medfusion 3010 and 3010A Syringe Infusion Pumps serviced during the same time…
- Classification
- Class II
- Units
- Distribution US nationwide, including PR, VI, GU, and MP. There was…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Smiths Medical ASD recalls
- 2023-02-08
USSmiths Medical ASD Inc. recalls CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24 3) REF 21-7302-24, 4) REF 21-7321-24, 5) REF 21-7322-24, 6)…
There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) False "No Disposable Attached (NDA)" Alarms
FDA · DeviceSmiths Medical ASD Inc.Worldwide Distribution: US (nationwide) and OUS countries of: CH, CA, ES, FR,…Official notice →- 2022-11-30
- US
Smiths Medical ASD Inc. recalls Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or V1.6.1 that have implemented the Smart Pump Programming…
Potential for delay in sending Infusion Start Messages to third-party Electronic Health Record systems which may affect infusion auto-programming on the pump and documentation
FDA · DeviceSmiths Medical ASD Inc.US distribution to states of: Indiana, Texas and VirginiaOfficial notice → - 2022-06-29
- US
Smiths Medical ASD Inc. recalls Medfusion Syringe Pump Models: 3500, 3500-0600-00, 3500-0600-01, 3500-0600-249, 3500-0600-50, 3500-0600-51, 3500-0600-82, 3500-306,…
Multiple issues with the potential for interruption of therapy or over-infusion: 1. Primary Audible Alarm (PAA), 2. Unanticipated Depleted Battery Alarms, 3. Time Base Alarm, 4. Intermittent Volume Over Time (IVOT) -…
FDA · DeviceSmiths Medical ASD Inc.Worldwide distribution. US nationwide including US Virgin Islands, Countries…Official notice → - 2021-11-03
- US
Smiths Medical ASD Inc. recalls Bivona Aire-Cuf Endotracheal Tube
Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm.
FDA · DeviceSmiths Medical ASD Inc.Worldwide distribution - US Nationwide distribution in the states of AL, AZ,…Official notice → - US
Smiths Medical ASD Inc. recalls Pneupac paraPac plus 300 ventilator kit, REF P300NGB
Two devices were labeled with the same serial number
- 2021-10-27
- US
Smiths Medical ASD Inc. recalls medfusion Stopcock, 1-way and 4-way, Model Numbers (REF): a. 081-101BE b. 081-101GE c. 081-101GEE d. 081-101NE e. 081-102NE f. 081-102RE…
Product has a lack of sterility assurance
FDA · DeviceSmiths Medical ASD Inc.International Distribution to countries of: Armenia, Austria, Germany, Great…Official notice →
Other drugs & medical recalls in the United States
- 2022-03-02
- US
RISING PHARMACEUTICALS recalls Methylphenidate Hydrochloride Chewable Tablets, 2.5 mg, 100-count bottle, Rx Only, Manufactured for: Rising Pharmaceuticals Inc., Saddle…
Failed Tablet Specifications: Recall of this drug product was voluntarily initiated by the manufacturer due to a market complaint, which stated that a tablet in the sealed bottle was twice larger in size when compared…
- US
Professional Disposables International, Inc. recalls Prevantics (chlorhexidine gluconate and isopropyl alcohol) Swab, 3.15% w/v and 70% v/v, packaged as a) One Swab,…
cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.
FDA · DrugProfessional Disposables International, Inc.Product was distributed nationwide in the USA and Puerto Rico.Official notice → - US
- 2022-02-23
- US
Howmedica Osteonics Corp. recalls Exeter V40 Cemented Hip (150mm) Stem, Part Number 0580-1-440
There is a potential label mix between certain lots of Exeter V40 Cemented Hip (125mm) Stem and Exeter V40 Cemented Hip (150mm) Stem.
FDA · DeviceHowmedica Osteonics Corp.The product was distributed to the following US states: MIOfficial notice → - US
Merete Medical GmbH recalls Merete PediatrOS RigidTack, REF CP20120, Size 20 mm, Sterile, Rx Only
Incorrect marketing label (25 mm) was applied to product size 20 mm.
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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Zenition 50, Model #718096
Firm discovered that the wireless foot switch can suddenly stop responding due to a firmware issue. If the wireless foot switch fails, there could be a delay or interruption of procedure if the hand switch is not used…
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Domestic distribution to AZ CA FL GA HI IL KS KY MA MD ME MI MN MS NC NE NJ NV…Official notice →