Customed Curations Kits Recalled Due to Sterilization Validation Issues
Customed, Inc. is recalling Curations Kits in Puerto Rico because the sterilization process and package integrity were not adequately validated.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving potential significant injury risks such as infection from non-sterile medical devices.
Plain-English summary
Customed, Inc. is recalling Curations Kits, which are used by medical staff for surgical and patient care procedures such as wound healing and suture removals. The recall was initiated because the company did not adequately validate or qualify the sterilization processes and package integrity for these products, which were released for distribution as sterile.
The affected products are Code 900913, specifically lots 140814826, 150116609, 150116610, 150111608, and 150518847. These items were distributed only in Puerto Rico.
This is an FDA Class II recall. Medical facilities should stop using the affected lots and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- CURATION KIT 10/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate
- Manufacturer
- Customed, Inc
- Category
- Medical Device — Surgical Kits
- Affected units
- 10
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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