Customed Irrigation Trays Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 4,800 irrigation trays distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
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: The recall involves a risk-of-harm product (sterile medical device) where the hazard is theoretical due to inadequate sterilization validation, and no injuries or illnesses have been reported in the source text.
Plain-English summary
Customed, Inc. is recalling 4,800 units of the Irrigation Tray with Bulb Syringe (Catalog number 900020). These products are used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation.
The recall was initiated because of inadequate validation and qualification of sterilization processes, as well as package integrity issues for products released for distribution as sterile. The affected lots include 150116955, 150116713, 150317568, 150418231, and 150518598, with expiration dates ranging from January 31, 2016, to May 31, 2016.
The products were distributed only in Puerto Rico. Medical facilities and consumers should stop using these trays and contact the recalling firm for further instructions.
The recalled product
- Product
- IRRIGATION TRAY W/BULB SYRINGE CUSTOMED 50/CS Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Manufacturer
- Customed, Inc
- Affected units
- 4,800
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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