Customed Ear Packs Recalled Due to Sterilization Validation Issues
Customed, Inc. is recalling specific lots of Ear Packs used in surgical procedures due to inadequate validation of sterilization processes and package integrity.
What this means for you
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 potential failure of sterilization and package integrity for a sterile medical device, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Customed, Inc. is recalling specific lots of Ear Packs, a medical device used by staff to perform 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 product is identified by code 9002423 and includes lots 141015705 (exp. 12/31/15), 141216302 (exp. 2/28/16), and 150518811 (exp. 5/31/16). The source text states that these products were distributed only in Puerto Rico.
Consumers and medical facilities should stop using the affected lots and contact the recalling firm for further instructions.
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
- 6
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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