Customed Recalls EO Sterilized Surgical Gowns Due to Packaging Integrity Concerns
Customed, Inc. is recalling EO sterilized surgical gowns because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source metadata explicitly identifies the agency classification as 'Class I'. According to the severity rubric, an FDA Class I recall mandates a score of 5 (Critical), as it represents a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or death.
Plain-English summary
Customed, Inc. is recalling EO sterilized surgical gowns (Code 900-3190) due to a potential compromise in packaging integrity. The affected products are extra-long, x-large gowns with towels and wraps, packaged in polyester/polyethylene breather bags with Tyvek double vents. The recall involves 5 lots totaling 312 units.
The company determined that the packaging integrity may be compromised on different catalog numbers. This defect could result in product contamination or a loss of sterility condition, which poses a risk of injury to patients. The agency has classified this as a Class I recall.
The affected lots are 140111070, 140211868, 140312153, 140412677, and 140513356. These products were distributed worldwide, including nationwide in the United States (specifically Florida, Puerto Rico, and USVI) and in the countries of Tortola, Trinidad, Dominican Republic, Costa Rica, and Mexico. Healthcare facilities and consumers should stop using these products and contact the recalling firm for instructions.
The recalled product
- Product
- Gown Impervious , Code 900-3190, contains: GOWN IMPERVIOUS EXTRA LONG X-LARGE WITH TOWEL & WRAP Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
- Manufacturer
- Customed, Inc
- Category
- Medical Device — Surgical Gowns
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 (2)
- 900-3190
- 5 lots: 140111070 140211868 140312153 140412677 140513356
Distribution
Part of a larger recall action
This product is one of 233 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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