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Windstone Medical Packaging dba Aligned Medical Solutions Issues Nationwide
Recall of Cardinal Health’s Monoject™ Flush Prefilled Saline Syringes placed into the
following kits; AMS-9041CP Leaderflex Insertion Kit
with Ultrasound, AMS-9046CP-1 Insertion Tray-RX, AMS8939A Universal Procedure
Pack w/Split Drape, AMS9957A Port Insertion Pack and AMS12149 Procedure Pack
October 20, 2021
1602 4th Avenue N. Billings, MT 59101
406-259-6387 – www.alignedmedicalsolutions.com
On August 19, 2021,
Aligned Medical Solutions initiated a nationwide recall of Cardinal
Health’s Monoject™ Flush Prefilled Saline Syringes
placed into 9,378 kits. Including;
·1 lot of AMS-9041CP Leaderflex
Insertion Kit with Ultrasound
·1 lot of AMS-9046CP-1 Insertion Tray-RX
·45 lots of AMS8939AUniversal Procedure Pack w/Split Drape
·1 lot of AMS9957A Port Insertion Pack
·3 lots of AMS12149 Procedure Pack
These convenience kits have been found
to contain the Cardinal Health’s Monoject™ Flush Prefilled Saline Syringe part # 8881570121,
which has been recalled for the potential
for the plunger to draw back after the air has been expelled and reintroduced
air back into the syringe. If a clinician is not aware of air being introduced
into the syringe, the clinician could inadvertently push air into the vascular
system creating the potential for an air embolism. Injection of air into the
vascular system can cause air embolism which can result in serious adverse
health consequences or death.
have affected product(s) should immediately
review their inventory and quarantine all affected kits. Contact the Quality
Department for further instructions on labeling and replacement product if
needed at 407-638-9924. Customers will be provided with a yellow label that is
to be placed on the packs containing the recalled Cardinal Health’s Monoject™ Flush Prefilled Saline Syringe. The label will
read as follows;
1.At the time the kit is
opened for use the prefilled syringe manufactured by Cardinal Health should be
identified, set aside and not used. Do not use the prefilled syringe in the
2.The recalled prefilled
syringe should be rendered unusable to protect against inadvertent use and
disposed or pursuant to the medical waste policies in effect at your
Consumers can request
replacement syringes by calling 407-638-9924.
Recalled Product(s) were manufactured
from 01/13/2020 to 10/14/2020 and distributed
from 01/23/2020 to 10/19/2020.
The following kit part
numbers and lot numbers containing the recalled /affected Cardinal Health Monoject™ Flush Prefilled Syringes have been recalled:
Product(s) can be identified
by the pack label inside the sterile
barrier of the convenience kit.
Aligned Medical Solutions has notified the FDA
of this action.
No injuries have been reported to date.
Aligned Medical Solutions is notifying its
distributors by email and will
arrange for labels to identify the
packs with the recalled syringe. Aligned Medical Solutions will also arrange
for replacement syringes to be sent for all recalled product(s).
Aligned Medical Solutions distributed these packs Nationwide.
Regular Mail or Fax:
Download form www.fda.gov/MedWatch/getforms.htm or
call 1-800-332-1088 to request a reporting form, then complete
and return to the address on the pre-addressed form, or submit by fax