Customed Wound Management Trays Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 1,248 wound management trays 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 is classified as FDA Class II and involves a risk-of-harm product (sterile medical device) where the hazard is theoretical (inadequate sterilization validation) and no specific injuries or illnesses are reported in the source text.
Plain-English summary
Customed, Inc. is recalling 1,248 Wound Management Trays (Code 9001154) that were distributed exclusively in Puerto Rico. The affected lots are 150116957 and 150217256, both with an expiration date of February 28, 2016. These trays are used by medical staff for surgical procedures and patient care, including wound healing, suture removals, and wound irrigation.
The recall was initiated because of inadequate validation and qualification of the sterilization processes and package integrity for these products, which were released for distribution as sterile. This classification indicates a potential risk that the products may not be sterile as intended.
Medical facilities and consumers in Puerto Rico who possess these specific trays should stop using them and contact Customed, Inc. for further instructions or a return. The U.S. Food and Drug Administration has classified this recall as Class II, meaning there is a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- WOUND MANAG.TRAY 24/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
- Affected units
- 1,248
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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