FDA announces recall on angiography syringes after 4 serious injuries to patients
The U.S. Food and Drug Administration (FDA) is spreading awareness of a letter Medical Action Industries sent to customers, wherein the device manufacturer effectively recalled syringes included in its surgical convenience kits.
These kits contain surgical instruments, wound dressings, relevant drugs and other products that clinicians need for a procedure, in this case angiography—a type of medical imaging used to visualize blood vessels.
Products contained within the Medical Action kits support the placement of a catheter in blood vessels, for the administration of contrast dye to support imaging necessary to measure blood flow, detect blockages and locate areas where there may be internal bleeding.
While most components of the kits are safe to use, the alert states that the rotating syringe adaptor on affected devices may unwind during use, resulting in a loose connection between the syringe and manifold.
This could lead to the connection unwinding, which may then introduce air into the line or expose the patient to pathogens. In either case, these accidents could be fatal. Medical Action did not report any deaths to the FDA associated with the issue. However, there have been four serious injuries to patients.
For now, this warning only constitutes an early alert, not a full recall. The FDA said it's monitoring the situation to see if there’s a need to escalate beyond this initial notice.
In any case, the dangerous syringes will need to be discarded and replaced—but the rest of the kits have been deemed safe to use.
What products are impacted?
The devices are officially called “Halyard Kit - Pack Cath BHH 5/Cs BANNER.” The following identifying numbers should be used to identify the convenience kits with the defective syringes.
- Model/Item Number: BHCA49K
- Unique Device Identifier: 0809160490294
- Lot numbers: 342509, 346066, 338434, 339423, 337365, 335489, 336189 and 336789
The FDA and Medical Action were clear to mention that all syringes contained within the above kits have the potential to fail. As a result, they must be removed from where they are used or sold.
Next steps
All known customers should have received letters from Medical Action suppliers outlining what to do to ensure the safety of the convenience kits.
Once identified in storage, all impacted products should be quarantined and segregated until a warning label is placed on packaging, alerting clinicians of the necessity of discarding the syringe contained within.
A template for these stickers was provided by Medical Action. They advised that the new label not obscure any of the other crucial warnings and instructions that may be on the outside of the surgical kits.
Syringes must be destroyed to ensure they are not used.
Both the company and the FDA added that, should there be some unusual situation where an alternative cannot be located and a patient is in urgent need of angiography, then extreme caution must be used to ensure the rotating adaptor on the syringes is working as intended and the connection remains secure.
The FDA said it is currently reviewing information about this potentially high-risk device issue and will keep the public informed as new information becomes available. The agency’s notice can be found by clicking here.
Chad is an award-winning writer and editor with over 15 years of experience working in media. He has a decade-long professional background in healthcare, working as a writer and in public relations.