Customed Foley Catheter Tray Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 380 units of Foley Catheter Trays 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. The hazard involves inadequate sterilization validation, which poses a risk of harm (infection) to patients, but the source text does not report any specific illnesses or injuries, fitting the criteria for a High severity score.
Plain-English summary
Customed, Inc. is recalling 380 units of Catalog Number 9001139 Foley Catheter Trays. These medical devices 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 sterilization processes, as well as package integrity issues for products released for distribution as sterile. The affected lots are SL15194, SL15210, SL15216, SL15218, SL15222, and SL15224, all with expiration dates of July 31, 2016.
The product was distributed only in Puerto Rico. No specific instructions for consumers are provided in the source text, but the recall is classified as Class II by the FDA.
The recalled product
- Product
- Catalog Number: 9001139 FOLEY CATHETER TRAY 18 FR -5CC-2WAY SILICONE COATED FOLEY 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
- 380
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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