Customed Minor Laceration Tray Recalled for Sterilization Validation Issues
Customed, Inc. is recalling Minor Laceration Trays because the sterilization processes and package integrity were not adequately validated.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations or injuries. The hazard is a potential failure of sterility due to validation issues, which fits the criteria for a moderate risk without reported harm.
Plain-English summary
Customed, Inc. is recalling 2,750 units of Minor Laceration Trays (Code 9001765). The recall was initiated because the company did not adequately validate or qualify the sterilization processes and package integrity for these products, which were released for distribution as sterile.
The affected products were distributed only in Puerto Rico. The recall includes specific lots with expiration dates ranging from January 31, 2016, to May 31, 2016.
Medical staff should stop using these trays and contact Customed, Inc. for instructions on how to return or dispose of the affected units.
The recalled product
- Product
- MINOR LACERATION TRAY CUSTOMED 50/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
- Manufacturer
- Customed, Inc
- Category
- Medical Device — Surgical Trays
- Affected units
- 2,750
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 170 recalled by Customed, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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