Customed Gauze Sponges Recalled for Sterilization Process Validation Issues
Customed, Inc. is recalling 19,328 units of 4"x4" 16-ply gauze sponges 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving critical quality control failures like sterilization validation in medical devices.
Plain-English summary
Customed, Inc. is recalling 19,328 units of 4"x4" 16-ply soft gauze sponges (1280 per case). These products are used by medical staff for surgical procedures and patient care tasks such as wound healing, suture removals, and wound irrigation. The recall was initiated because of inadequate validation and qualification of the sterilization processes, as well as package integrity issues for products released for distribution as sterile.
The affected lots are 141015896, 141216338, and 150418409, all with an expiration date of 12/31/99. The product code is 9004165. Distribution was limited to Puerto Rico.
This is an FDA Class II recall. Medical facilities and consumers should stop using the affected products and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- GAUZE SPONGE 4"X4" 16 PLY SOFT 1280/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
- 19,328
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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