Customed Universal Drainage Trays Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 960 Universal Drainage 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity score (2) when no specific hospitalizations or serious injuries are reported in the source text.
Plain-English summary
Customed, Inc. is recalling 960 units of Universal Drainage Trays (Catalog number 900032) that were distributed only in Puerto Rico. The affected lots are 141015606 (exp. 3/31/16), 150318100 (exp. 4/30/16), and 150619057 (exp. 6/30/16). These trays are used by medical staff for surgical procedures and patient care tasks such as wound healing, suture removals, and wound irrigation.
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. This FDA Class II recall indicates that use of the product could create a temporary or medically reversible health risk, or where the probability of serious adverse health consequences is remote.
Medical facilities and consumers in Puerto Rico who possess these specific lots should stop using the trays and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- UNIVERSAL DRAINAGE TRAY CUSTOMED 20/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
- 960
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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