Customed Wound Management Tray Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 200 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 due to inadequate sterilization validation, with no reported injuries or illnesses in the source text.
Plain-English summary
Customed, Inc. is recalling 200 units of the Wound Management Tray (Catalog Number 9001456). These trays are used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, and wound irrigation. The affected units were distributed only in Puerto Rico.
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 specific lots involved are SL15197, SL15201-01, SL15218, and SL15266, all with expiration dates of April 30, 2016, or May 31, 2016.
The U.S. Food and Drug Administration has classified this as a Class II recall. Medical facilities and consumers who have these specific trays should stop using them and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Catalog Number: 9001456 WOUND MANAGEMENT TRAY 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
- 200
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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