Customed REYITO PLUS Urology Surgical Pack Recalled for Sterilization Defects
Customed, Inc. is recalling 35 units of REYITO PLUS Urology Surgical Packs 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 the source text does not report any illnesses or injuries, fitting the High severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Customed, Inc. is recalling 35 units of the REYITO PLUS Urology Surgical Pack (Catalog Number 9001460). 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 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 are SL15202 (150619550), SL15202 (150619235), SL15209 (150719642), and SL15209 (150619550), with dates ranging from June 30, 2016, to July 31, 2016.
The products were distributed only in Puerto Rico. The source text does not specify instructions for consumers or medical facilities regarding the return or disposal of these items.
The recalled product
- Product
- Catalog Number: 9001460 REYITO PLUS UROLOGY SURGICAL PACK 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
- 35
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 100 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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