Customed Gauze Sponges Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling 3,000 units of gauze sponges 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 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 in the source text.
Plain-English summary
Customed, Inc. is recalling 3,000 units of 2"x2" 8-ply cotton gauze sponges. These products are used by medical staff for surgical procedures and patient care, including wound healing, suture removals, and wound irrigation.
The recall was initiated because of inadequate validation and qualification of the sterilization processes, as well as issues with package integrity for products released for distribution as sterile. The affected lots are 141216321, 150217375, and 150217354, all with an expiration date of 12/31/99.
The products were distributed only in Puerto Rico. Medical facilities and consumers who have these specific lots should stop using them and contact the manufacturer for further instructions.
The recalled product
- Product
- GAUZE SPONGE 2"X2" 8PLY COTTON 1500PK/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
- Category
- Medical Device — Surgical Gauze
- Affected units
- 3,000
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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