Customed Recalls Surgical Gowns Due to Sterilization Validation Issues
Customed, Inc. is recalling 180 surgical gowns distributed in Puerto Rico because of 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 3/5 (High).
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 surgical gowns) 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 180 units of surgical gowns (30/CS) due to inadequate validation and qualification of sterilization processes and package integrity. These products were released for distribution as sterile.
The affected products are identified by code 9001579 and lot 150518997, with an expiration date of May 31, 2016. The recall is limited to products distributed only in Puerto Rico.
These gowns are used by medical staff to perform surgical procedures and patient care procedures, such as wound healing, suture removals, and wound irrigation. Consumers and medical facilities should stop using the affected products and contact the recalling firm for further instructions.
The recalled product
- Product
- Gown, surgical 30/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
- 180
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:9001579 Lots: 150518997 exp. 5/31/16 150518997 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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