Customed Labor and Delivery Kits Recalled for Sterilization Defects
Customed, Inc. is recalling 300 Labor and Delivery kits 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 (potential lack of sterility) and no injuries or illnesses have been reported, which aligns with the High severity criteria.
Plain-English summary
Customed, Inc. is recalling 300 units of Labor and Delivery kits (Code 900419) that were distributed exclusively in Puerto Rico. These medical devices are used by medical staff to perform surgical procedures and patient care tasks, including wound healing, suture removals, and wound irrigation.
The recall was initiated because the company identified inadequate validation and qualification of the sterilization processes and package integrity for these products. The affected units were released for distribution as sterile, but the validation issues raise concerns about whether they were properly sterilized.
The recall involves specific lots with expiration dates ranging from October 31, 2015, to May 31, 2016. The source text does not report any illnesses or injuries associated with the use of these products. Medical facilities that received these kits should stop using them and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- LABOR & DELIVERY 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
- Category
- Medical Device — Surgical Kits
- Affected units
- 300
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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