Basin Set Medical Device Kit Contents Do Not Match Label
American Contract Systems, Inc. is recalling a surgical basin set (MEBS42K) because the kit contents do not match the labeled contents. The mismatch could result in improper surgical preparation.
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 medical device labeling error creates a risk of harm due to mismatch between package contents and label, which could lead to improper surgical preparation. However, no adverse events have been reported, placing this at the upper limit for theoretical hazards without reported injury.
Plain-English summary
American Contract Systems, Inc. is recalling the BASIN SET, MEBS42K, a general surgical kit distributed nationwide. Approximately 1,504 trays are affected, identified by UDI/DI 00191072151742, Batch/Lot Number 833221, with an expiration date of June 16, 2023.
The kit contains components intended for a Single Basin Set, but the package labeling does not accurately reflect this. This mismatch between actual and labeled contents could result in improper surgical preparation if healthcare providers rely on the label to verify kit contents before use.
No adverse events or injuries have been reported in connection with this labeling error. Healthcare facilities that have received this product should verify actual kit contents match their intended use before incorporating the kit into surgical procedures. Consumers with questions should contact American Contract Systems, Inc.
The recalled product
- Product
- BASIN SET, MEBS42K, general surgical kit
- Manufacturer
- American Contract Systems, Inc.
- Hazard
- label-content-mismatch
- use-error-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 (3)
- UDI/DI 00191072151742
- Batch/Lot No. 833221
- exp 6/16/2023
Distribution
Distributed nationwide across the United States.
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