FDA Reports Recall of Custom Convenience Kits Because of Prefilled Syringe Plunger Defect
On November 9, 2021, the U.S. Food and Drug Administration (FDA) reported (https://www.fda.gov/medical-devices/medical-device-recalls/aligned-medical-solutions-doing-business-windstone-medical-packaging-inc-recalls-custom-convenience) Aligned Medical Solutions’ recall of its custom convenience kits because of the potential for the plunger of the Cardinal Health monoject flush prefilled syringe (0.9% sodium chloride) to draw back after the air has been expelled and reintroduce air back into the syringe. FDA identified the recall as a class I recall, the most serious type of recall.
FDA reported that if a clinician is not aware of air being reintroduced into the syringe, they may push air into the vascular system and create the potential for an air embolism. The use of the affected product could cause serious adverse health consequences, including death. All other components in the kits are not affected by the recall.
To date, Aligned Medical Solutions has received 42 reports of plunger retraction and introduction of air into the Cardinal Health monoject flush prefilled syringe (0.9% sodium chloride). It has had no reports of complaints, injuries, or deaths.
The recall affects the following custom convenience kits (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=189592), distributed between January 23–October 19, 2020, that contain the Cardinal Health monoject flush prefilled syringe (0.9% sodium chloride):
|
Product |
Model Number |
Lot Number |
|
Leaderflex insertion kit with ultrasound |
AMS-9041CP |
136833 |
|
Insertion tray-RX |
AMS-9046CP-1 |
137794 |
|
Universal procedure pack with split drape |
AMS8939A |
140390 |
|
Universal procedure pack with split drape |
AMS8939A |
141088 |
|
Universal procedure pack with split drape |
AMS8939A |
141096 |
|
Universal procedure pack with split drape |
AMS8939A |
141100 |
|
Universal procedure pack with split drape |
AMS8939A |
141102 |
|
Universal procedure pack with split drape |
AMS8939A |
146039 |
|
Universal procedure pack with split drape |
AMS8939A |
146349 |
|
Universal procedure pack with split drape |
AMS8939A |
147902 |
|
Universal procedure pack with split drape |
AMS8939A |
147903 |
|
Universal procedure pack with split drape |
AMS8939A |
148414 |
|
Universal procedure pack with split drape |
AMS8939A |
148452 |
|
Universal procedure pack with split drape |
AMS8939A |
148640 |
|
Universal procedure pack with split drape |
AMS8939A |
149132 |
|
Universal procedure pack with split drape |
AMS8939A |
149135 |
|
Universal procedure pack with split drape |
AMS8939A |
149485 |
|
Universal procedure pack with split drape |
AMS8939A |
141087 |
|
Universal procedure pack with split drape |
AMS8939A |
141097 |
|
Universal procedure pack with split drape |
AMS8939A |
145615 |
|
Universal procedure pack with split drape |
AMS8939A |
146351 |
|
Universal procedure pack with split drape |
AMS8939A |
146766 |
|
Universal procedure pack with split drape |
AMS8939A |
146768 |
|
Universal procedure pack with split drape |
AMS8939A |
146905 |
|
Universal procedure pack with split drape |
AMS8939A |
146908 |
|
Universal procedure pack with split drape |
AMS8939A |
148638 |
|
Universal procedure pack with split drape |
AMS8939A |
149137 |
|
Universal procedure pack with split drape |
AMS8939A |
149138 |
|
Universal procedure pack with split drape |
AMS8939A |
149484 |
|
Universal procedure pack with split drape |
AMS8939A |
149486 |
|
Universal procedure pack with split drape |
AMS8939A |
141101 |
|
Universal procedure pack with split drape |
AMS8939A |
148410 |
|
Universal procedure pack with split drape |
AMS8939A |
148411 |
|
Universal procedure pack with split drape |
AMS8939A |
148639 |
|
Universal procedure pack with split drape |
AMS8939A |
149133 |
|
Universal procedure pack with split drape |
AMS8939A |
141098 |
|
Universal procedure pack with split drape |
AMS8939A |
146037 |
|
Universal procedure pack with split drape |
AMS8939A |
148409 |
|
Universal procedure pack with split drape |
AMS8939A |
148413 |
|
Universal procedure pack with split drape |
AMS8939A |
148450 |
|
Universal procedure pack with split drape |
AMS8939A |
149131 |
|
Universal procedure pack with split drape |
AMS8939A |
149134 |
|
Universal procedure pack with split drape |
AMS8939A |
149136 |
|
Universal procedure pack with split drape |
AMS8939A |
148412 |
|
Universal procedure pack with split drape |
AMS8939A |
148451 |
|
Universal procedure pack with split drape |
AMS8939A |
148636 |
|
Universal procedure pack with split drape |
AMS8939A |
141717 |
|
Port insertion pack |
AMS9957A |
147773 |
|
Procedure pack |
AMS12149 |
145718 |
|
Procedure pack |
AMS12149 |
146897 |
|
Procedure pack |
AMS12149 |
148612 |
Aligned Medical Solutions sent a recall letter to customers with information on how to identify the affected products, complete a recall reply form, and request replacement syringes. Healthcare providers and patients with questions regarding the recall should contact Aligned Medical Solutions at 406-259-6387 or 407-865-7211.
Healthcare professionals and consumers should report any adverse reactions or quality problems (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm) they experienced using the product to MedWatch, FDA’s Safety Information and Adverse Event Reporting Program.