Customed Suture Removal Kits Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 20,200 Suture Removal Kits 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 involves a risk-of-harm product (sterile medical device) where the hazard is theoretical (inadequate sterilization validation) and no injuries or illnesses have been reported, fitting the 'High' severity criteria.
Plain-English summary
Customed, Inc. is recalling 20,200 units of the Suture Removal Kit (Catalog number 900010). These kits are used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation. The affected lots have expiration dates ranging from October 31, 2015, to May 31, 2016.
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 source text does not report any specific illnesses or injuries associated with the use of these products.
The affected products were distributed only in Puerto Rico. Medical facilities and consumers who have these specific kits should stop using them and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- SUTURE REMOVAL KIT CUSTOMED 100/CS Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Manufacturer
- Customed, Inc
- Affected units
- 20,200
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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