HSG Procedure Trays With Incorrect Sterility Labeling on Iodine Pouches
CooperSurgical HSG Procedure Trays contain non-sterile iodine pouches incorrectly labeled as sterile. The mislabeling affects 171 units distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall with mislabeling causing potential infection risk during sterile procedures, but no reported illnesses or injuries to date. The hazard represents a genuine risk of harm in surgical applications despite the absence of reported adverse events.
Plain-English summary
CooperSurgical, Inc. is recalling HSG Procedure Trays (Model 6050T) due to a labeling error. The affected trays contain iodine pouches that are non-sterile, but the peel-away lid labels incorrectly identify them as sterile.
The HSG Procedure Tray is used in hysterosalpingography and sonohysterography procedures, which are sterile medical procedures. Using non-sterile materials in sterile procedures creates a risk of infection.
The recall affects 171 units distributed nationwide across all U.S. states and Washington DC. Affected lot numbers are 339331, 339327, 339333, 339334, and 343007 (UDI-DI: 60888937003262).
Healthcare facilities and providers who have received these trays should immediately stop using them and contact CooperSurgical for replacement units. If the product has already been used, consult with appropriate medical professionals regarding patient follow-up.
The recalled product
- Product
- HSG Procedure Tray. Model Number: 6050T. The HSG Procedure Tray is for use in hysterosalpingography and sonohysterography procedures.
- Manufacturer
- CooperSurgical, Inc.
- Category
- Medical Device — Surgical Trays
- Hazard
- mis-labeling
- infection-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Model Number: 6050T. UDI-DI 60888937003262. Lot Numbers: 339331
- 339327
- 339333
- 339334
- 343007.
Distribution
Distributed nationwide across the United States.
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