Customed EENT Pack I Recalled Due to Sterilization Validation Issues
Customed, Inc. is recalling EENT Pack I sterile medical packs 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 the potential for infection due to inadequate sterilization validation, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Customed, Inc. is recalling EENT Pack I (1) 10/CS sterile medical packs. These products are used by medical staff to perform surgical procedures and patient care procedures, such as wound healing, suture removals, and wound irrigation. The recall is limited to products distributed in Puerto Rico.
The recall was initiated because of inadequate validation and qualification of sterilization processes and package integrity for products released for distribution as sterile. This means the manufacturer could not fully verify that the products were properly sterilized and that the packaging maintained its integrity to keep the contents sterile.
Affected lots include 150116588, 150116586, and 150116587, all with an expiration date of 1/31/16. The product code is 9002498. Medical facilities and consumers who have these specific products should stop using them and contact the manufacturer or their supplier for instructions on return or replacement.
The recalled product
- Product
- EENT PACK I (1) 10/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
- Category
- Medical Device — Surgical Packs
- Affected units
- 10
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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