Customed Wound Manage II Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling Wound Manage II kits 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 hazard is theoretical (inadequate sterilization validation) and no injuries or illnesses have been reported.
Plain-English summary
Customed, Inc. is recalling 1,020 units of Wound Manage II (Catalog Number 9001198) medical kits. These products 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 products released for distribution as sterile. The affected lots were distributed only in Puerto Rico.
Medical facilities and consumers who possess these specific lots should stop using the products and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Catalog Number: 9001198 WOUND MANAGE II 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 Kits
- Affected units
- 1,020
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.
See all 100 products in this recall →Related recalls
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