Customed Surgical Gowns Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling surgical gowns due to inadequate validation of sterilization processes and package integrity. The products were distributed only in Puerto Rico.
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 safety aspects like sterilization validation for sterile medical devices.
Plain-English summary
Customed, Inc. is recalling 10,805 units of SURG GOWN POLYREINF LGE CUSTOM 28/CS. These medical gowns are used by staff for surgical procedures and patient care tasks such as wound healing and suture removals. The recall was initiated because of inadequate validation and qualification of sterilization processes, as well as package integrity issues for products released as sterile.
The affected lots include 141116021, 150117022, 150317997, 150418241, and 150518822, with expiration dates ranging from November 30, 2015, to May 31, 2016. The products were distributed only in Puerto Rico.
The FDA has classified this as a Class II recall. Consumers and medical facilities should stop using the affected gowns and contact the manufacturer for instructions on return or disposal.
The recalled product
- Product
- SURG GOWN POLYREINF LGE CUSTOM 28/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 Gowns
- Affected units
- 10,805
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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