Customed Gauze Recalled Due to Sterilization Validation Deficiencies
Customed, Inc. is recalling 2-inch by 2-inch gauze pads because of 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 medical device with a risk of harm due to inadequate sterilization validation, but the source text does not report any illnesses or injuries, meeting the criteria for a High severity score.
Plain-English summary
Customed, Inc. is recalling 162,000 units of 2-inch by 2-inch gauze pads. The product is used by medical staff for surgical procedures and patient care tasks such as wound healing, suture removals, and wound irrigation.
The recall was initiated due to inadequate validation and qualification of sterilization processes, as well as package integrity issues for products released for distribution as sterile. The affected lots are 141015876, 141216322, 150217376, and 150518683, all with an expiration date of 12/31/99.
The product was distributed only in Puerto Rico. Consumers and medical facilities should stop using the affected gauze and contact the recalling firm for further instructions.
The recalled product
- Product
- GAUZE 2" X 2" PRODUCTION ONLY 1500PK/CS CUSTOMED 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
- Affected units
- 162,000
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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