July 2019 FDA Med Device Recalls - Acela Medical

FDA Medical Device Recall Series - July 2019

July 2019 FDA Recall List

7/1/2019 Edwards Lifesciences Recalls the IntraClude Intra-Aortic Occlusion Device Due to Risk of Balloon Rupture

Models Affected:

ICF100
UDI code (01) 00690103190007

Lots:

60972890
61078031
61097633
61139239
61259627
61259628
61713218
61723505
61898939

7/1/2019 Becton Dickinson & Company (BD) Recalls SmartSite Syringe Administration Set Due to Risk of Leaks

Models Affected:

10798696

Lots:

18046218

7/12/2019 Hamilton Medical AG Recalls Hamilton-G5 Ventilators Due to Potential for Sporadic Error Message Resulting in the Ventilator to Cease Ventilation and Enter Ambient State

Models Affected:

Hamilton Medical AG Hamilton-G5 Ventilator (PN 159001)

Lots:

All serial numbers below 16192 with software versions ≤ 2.60

7/12/2019 GE Healthcare, LLC Recalls Giraffe Infant Warmers and Panda i-Res Infant Warmers Due to Bedside Panels and Latch Areas Cracking or Breaking

Models Affected:

2063568-001-XXXXXX
2063570-001-XXXXXX
M1112198-XXXXXX
M1118179-XXXXXX

Lots:

All lots are involved

7/17/2019 Teleflex Recalls NEONATAL ConchaSmart Breathing Circuit Due to Circuit Cracks

Models Affected:

Product Codes: 870-07KIT, 870-09KIT

Lots:

74L1802044
74L1802045

7/18/2019 Becton Dickinson (BD) (CareFusion 303, Inc.) Recalls Alaris Pump Module Model 8100 Bezel Assembly Which Could Result in Free Flow, Over-Infusion, Under-Infusion, or Interruption of Infusion

Models Affected:

Model 8100

Lots:

Manufacturing Dates: April 2011 to June 2017*

* This product was initially recalled on August 9, 2017 (FDA Recall # Z-0026-2018). The firm subsequently expanded the recall on April 13, 2018 to expand the volume of product impacted. On February 1, 2019, BD further expanded the recall to include all Alaris Pump Modules Model 8100 manufactured between April 2011 and June 2017.

7/18/2019 Becton Dickinson (BD) Recalls Alaris Infusion Sets for the Alaris Pump Model 8100 Due to Potential for Tube Collapse that May Cause Unintended Delivery or Faster than Expected Delivery of Medication

Models Affected:

Alaris Pump Model 8100 Infusion Set

Lots:

See full list of affected devices in BD recall notice

7/23/2019 Datascope/Getinge Recalls Cardiosave Hybrid, Cardiosave Rescue, CS300 and CS100/100i Intra-Aortic Balloon Pumps (IABP) Due to Potential Battery Failure

Models Affected:

Cardiosave Hybrid IABP
Cardiosave Rescue IABP
CS300 IABP
CS100/100i IABP

Lots:

All lot numbers

If your organization needs help coordinating logistics, etc. related to any of the above Recalls, please don’t hesitate to contact us.