Customed recalls cataract packs due to sterilization validation issues
Customed, Inc. is recalling cataract packs distributed in Puerto Rico because the company could not adequately validate the sterilization processes and package integrity for these sterile products.
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 surgical packs) where the failure of sterilization validation creates a potential for infection, but the source text does not report any actual illnesses or injuries.
Plain-English summary
Customed, Inc. is recalling 1,038 units of CATARACT PACK 6/CS. These medical device packs are used by medical staff to perform surgical procedures and patient care procedures, such as wound healing, suture removals, and irrigation. The recall was initiated because of inadequate validation and qualification of the sterilization processes, as well as package integrity issues for products that were released for distribution as sterile.
The affected products were distributed only in Puerto Rico. The recall includes specific lots with expiration dates ranging from October 31, 2015, to June 30, 2016. The source text does not report any illnesses or injuries associated with the use of these products.
Healthcare facilities and consumers who have these specific lots should stop using them and contact Customed, Inc. or the FDA for further instructions on how to return or dispose of the products.
The recalled product
- Product
- CATARACT PACK 6/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate
- Manufacturer
- Customed, Inc
- Category
- Medical Device — Surgical Packs
- Affected units
- 1,038
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.
See all 170 products in this recall →Related recalls
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