Customed Surgical Gowns Recalled for Sterilization Validation Issues
Customed, Inc. is recalling surgical gowns 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The source text does not report any illnesses, injuries, or hospitalizations, and the hazard is related to process validation rather than a confirmed high-risk pathogen or structural defect causing immediate harm.
Plain-English summary
Customed, Inc. is recalling specific lots of Customed Surgical Gowns (Poly Reinforced, XL/XLong, 40/CS). The recall was initiated because of inadequate validation and qualification of the sterilization processes used for these products. Additionally, there were concerns regarding the package integrity for the products that were released for distribution as sterile.
The affected products were distributed only in Puerto Rico. The specific lot number is 150317846, with an expiration date of 5/31/16. These gowns are used by medical staff to perform surgical procedures and patient care procedures, such as wound healing, suture removals, and wound irrigation.
Medical facilities and consumers in Puerto Rico should check their inventory for this specific lot number and stop using the affected gowns. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- GOWN SURG. POLY REINF. XL XLONG 40/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 Gowns
- Affected units
- 40
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Code:9002565 Lots: 150317846 exp. 5/31/16
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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