Customed Impervious Gowns Recalled for Sterilization Validation Defects
Customed, Inc. is recalling 144 cases of impervious gowns 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.
Plain-English summary
Customed, Inc. is recalling 144 cases of Gown Impervious Extra Long (24/CS). These gowns are used by medical staff for surgical procedures and patient care tasks such as wound healing, suture removals, and wound irrigation. The recall was initiated because of inadequate validation and qualification of the sterilization processes, as well as issues with package integrity for products released for distribution as sterile.
The affected products were distributed only in Puerto Rico. The recall covers specific lots with expiration dates ranging from November 2015 to May 2016. The source text does not report any illnesses, injuries, or deaths associated with these products.
Healthcare facilities and consumers should stop using the affected gowns and contact Customed, Inc. for further instructions on how to return or dispose of the products.
The recalled product
- Product
- GOWN IMPERVIOUS EXTRA LONG 24/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 Gowns
- Affected units
- 144
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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