Customed Open Heart Trays Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 56 Open Heart 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 involves a risk-of-harm product (sterile medical device) where the hazard is theoretical (inadequate sterilization) and no injuries or illnesses have been reported, fitting the 'High' severity criteria.
Plain-English summary
Customed, Inc. is recalling 56 units of the Open Heart Tray, a medical device used by staff for surgical and patient care procedures. The recall was initiated because of inadequate validation and qualification of sterilization processes, as well as package integrity issues for products released as sterile.
The affected trays were distributed only in Puerto Rico. Specific lot numbers and expiration dates are listed in the official recall record. The source text does not report any illnesses or injuries associated with this recall.
Healthcare facilities should stop using the affected trays and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- OPEN HEART TRAY 1/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
- 56
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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