Customed C-Section Kits Recalled for Sterilization Validation Defects
Customed, Inc. is recalling 92 C-Section Kits due to inadequate validation of sterilization processes and package integrity. The products were distributed only in Puerto Rico.
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 injury has not yet been reported, fitting the High severity criteria for theoretical hazards without confirmed illness.
Plain-English summary
Customed, Inc. is recalling 92 units of the C-SECTION PK 2/CS product. This medical device is used by medical staff to perform surgical procedures and patient care procedures, including wound healing, suture removals, and 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 products were distributed only in Puerto Rico. 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 this recall.
Healthcare facilities and consumers should stop using the affected C-Section Kits and contact Customed, Inc. for further instructions on how to return or dispose of the products.
The recalled product
- Product
- C-SECTION PK 2/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate
- Manufacturer
- Customed, Inc
- Category
- Medical Device — Surgical Kits
- Affected units
- 92
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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