Customed Face Pack Recalled for Sterilization Process Validation Issues
Customed, Inc. is recalling 24 units of Face Pack MRT 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 involves a risk-of-harm product (sterile medical device) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Customed, Inc. is recalling 24 units of the Face Pack MRT, a medical device used by staff for surgical and patient care procedures. The recall was initiated because of inadequate validation and qualification of the sterilization processes, as well as issues with package integrity for products released as sterile.
The affected products were distributed only in Puerto Rico. The specific lots involved are 150116641, 150116640, and 150116639, all with an expiration date of 1/31/16. The product code is 9002654.
Consumers and medical facilities should stop using these specific lots and contact the recalling firm for further instructions.
The recalled product
- Product
- FACE PACK MRT 8/CS CUSTOMED 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
- 24
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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