FDA Reports Recall of Custom Convenience Kits Because of Prefilled Syringe Plunger Defect

November 12, 2021

On November 9, 2021, the U.S. Food and Drug Administration (FDA) reported 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 Reports Recall of Custom Convenience Kits Because of Prefilled Syringe Plunger Defect

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, 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 they experienced using the product to MedWatch, FDA’s Safety Information and Adverse Event Reporting Program.


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