Customed Ear Pack Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling 48 units of Ear Packs 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 involves a risk-of-harm product (sterile medical device) where the hazard is theoretical due to process validation failures, with no reported injuries or illnesses in the source text.
Plain-English summary
Customed, Inc. is recalling 48 units of the EAR PACK 3/CS, a medical device used by staff for surgical and patient care procedures such as wound healing and suture removals. 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 products were distributed only in Puerto Rico. Specific lot numbers and expiration dates are listed in the recall documentation, including lots expiring between December 2015 and June 2016.
Healthcare facilities and consumers should stop using these specific lots of Ear Packs and contact the recalling firm or the FDA for further instructions on how to return or dispose of the products.
The recalled product
- Product
- EAR PACK 3/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
- 48
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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