Customed Gauze Sponges Recalled for Sterilization Process Validation Issues
Customed, Inc. is recalling sterile gauze sponges 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. The hazard involves a risk-of-harm product (sterile medical device) where the source text does not report specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Customed, Inc. is recalling sterile gauze sponges (4"x4" 16 ply) because of inadequate validation and qualification of sterilization processes and package integrity. The products were released for distribution as sterile.
The recall affects approximately 25,471.94 units distributed only in Puerto Rico. The affected lots include 141015903, 141216348, 150317999, and 150418415, all with an expiration date of 12/31/99.
These products are used by medical staff for surgical procedures and patient care, such as wound healing and suture removals. The recall is classified as Class II by the FDA.
The recalled product
- Product
- GAUZE SPONGE 4"X4" 16 PLY XRD 1280/CS (STERILE) 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 Gauze
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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