Customed Recalls Laparoscopy Chole 4/CS Due to Sterilization Validation Issues
Customed, Inc. is recalling specific lots of Laparoscopy Chole 4/CS in Puerto Rico because the sterilization processes and package integrity were not adequately validated.
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.
Plain-English summary
Customed, Inc. is recalling specific lots of the Laparoscopy Chole 4/CS medical device. This product is used by medical staff to perform surgical procedures and patient care procedures, such as wound healing, suture removals, and wound irrigation. The recall is limited to products distributed only in Puerto Rico.
The recall was initiated due to inadequate validation and qualification of sterilization processes, as well as package integrity issues for products released for distribution as sterile. The affected lots include 140915489, 141216336, 150318022, 150318023, 150418408, 150418407, 150418588, 150619282, and 150619370, with expiration dates ranging from October 31, 2015, to June 30, 2016.
Healthcare facilities and consumers in Puerto Rico should check their inventory for these specific lot numbers and stop using the affected products. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- LAPAROSCOPY CHOLE 4/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
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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