Customed Gauze Sponges Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling 18,000 units of 2"x2" 4-ply sterile gauze sponges distributed in Puerto Rico 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 18,000 units of 2"x2" 4-ply sterile gauze sponges (2 per package, 1500 packages per case). The product is 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 sterilization processes, as well as package integrity issues for products released for distribution as sterile.
The affected lots are 141015873, 150116784, 150217484, and 150518681, all with an expiration date of 12/31/99. The product code is 9002042. These items were distributed only in Puerto Rico.
Medical facilities and consumers in Puerto Rico should stop using the affected gauze sponges and contact Customed, Inc. for further instructions or a return.
The recalled product
- Product
- GAUZE SPONGES 2"x2" 4 PLY ST 2/PK 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
- 18,000
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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