Customed Wound Management Tray III Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 620 Wound Management Tray III units distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 failure of sterilization validation poses a theoretical risk of infection, but the source text does not report any specific illnesses or injuries.
Plain-English summary
Customed, Inc. is recalling 620 units of the Wound Management Tray III (Catalog Number 900540). These trays are used by medical staff to perform surgical procedures and patient care procedures, including wound healing, suture removals, and wound irrigation. The affected lots are SL15195-01, SL15195-02, and SL15218, all with a use-by date of July 31, 2016.
The recall was initiated because of inadequate validation and qualification of the sterilization processes and package integrity for products released for distribution as sterile. This means the manufacturer could not verify that the sterilization process was effective or that the packaging maintained the sterile state of the devices.
The affected products were distributed only in Puerto Rico. Medical facilities and consumers who have these specific trays should stop using them and contact Customed, Inc. for further instructions or a return.
The recalled product
- Product
- Catalog Number: 900540 WOUND MANAGEMENT TRAY III 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 Trays
- Affected units
- 620
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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