Customed Universal Drainage Tray Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 900 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 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 the hazard involves a risk of harm (infection) from potentially non-sterile medical devices, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Customed, Inc. is recalling 900 units of the Universal Drainage Tray (Catalog Number 900032). 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 the sterilization processes and package integrity for products released for distribution as sterile. This means the manufacturer could not fully verify that the sterilization process was effective or that the packaging maintained the sterile status of the devices.
The affected lots include SL15173, SL15174, SL15175, SL15209, SL15210, SL15216, SL15224, SL15229, SL15258, SL15259, and SL15260. Medical facilities and consumers who possess these specific trays should stop using them and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- Catalog Number: 900032 UNIVERSAL DRAINAGE 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
- 900
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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