Customed Urology Packs Recalled for Sterilization Process Validation Issues
Customed, Inc. is recalling 130 packs of Urology Customed Packs 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 medical device with a risk of harm due to inadequate sterilization validation, but no injuries or illnesses have been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Customed, Inc. is recalling 130 packs of Urology Customed Packs. These products are used by medical staff to perform surgical procedures and 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 are 141015711, 150116693, 150317599, 150317598, 150317597, and 150317596, with expiration dates ranging from November 30, 2015, to March 31, 2016.
The products were distributed only in Puerto Rico. Medical facilities and consumers should stop using these products and contact the recalling firm for further instructions.
The recalled product
- Product
- UROLOGY CUSTOMED PACK 5/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 Packs
- Affected units
- 130
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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