FDA recalls surgical packs due to risk of microbial contamination
The U.S. Food and Drug Administration (FDA) has issued a Class I recall on Alcon Custom Paks—sealed pouches that contain sterile bandages, syringes and other devices necessary for surgical procedures. Certain lots of these kits may contain pouches with ineffective seals, meaning the products within could be compromised.
In response, Alcon is recalling any lot linked to the defective packaging. The FDA warns that use of non-sterile surgical devices dramatically increases the risk that a patient will develop a potentially life-threatening infection as a result of microbial contamination.
To date, there have been no reported injuries or deaths associated with the kits. However, given the serious threat they pose to patient health, they must be removed from where used or sold immediately.
What’s being recalled?
The Alcon Custom Paks being recalled are specifically created to be used by ophthalmic surgeons to support a variety of procedures on the eyes. Below are specifics on the recalled lots.
Catalog Number | Unique Device Identifier (UDI) | Lot number |
9903-20 | 17PJ9X | |
17188-04 | 17PJAY | |
19762-03 | 17PU09 | |
19203-04 | 17PMWE | |
19203-04 | 17PTXP | |
17957-10 | 17PTXY |
Next steps
Any supply house, hospital or surgery center in possession of any of the products affected by this recall must stop using them immediately. Both Alcon and the FDA ask that inventory be checked to see if any product in storage matches the recalled lot numbers.
Impacted custom packs must be segregated and destroyed immediately. Users are asked to contact Alcon to initiate a refund or replacement. Customers in the U.S. can call the company at 1-800-757-9780, option 5.
Any adverse reactions or patient safety issues associated with the recalled products can also be reported at that number.
To spread awareness of the recall, the FDA asks that the notice be shared. It 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.