Customed Recalls Surgical Gowns Due to Sterilization Validation Issues
Customed, Inc. is recalling 1,148 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 due to process validation issues, and no injuries or illnesses have been reported.
Plain-English summary
Customed, Inc. is recalling 1,148 units of Catalog Number 900522 Surgical Gowns. These gowns are used by medical staff for surgical procedures and patient care tasks such as wound healing, suture removals, and wound irrigation. The affected products were distributed only in Puerto Rico.
The recall was initiated due to inadequate validation and qualification of sterilization processes, as well as package integrity issues for products released for distribution as sterile. The source text does not report any specific illnesses or injuries associated with this recall.
Consumers and healthcare facilities should stop using the affected gowns and contact Customed, Inc. for further instructions on return or disposal.
The recalled product
- Product
- Catalog Number: 900522 SURGICAL GOWN SMS POLY-REINFORCED, RAGLAN SLEEVE, AAMI LEVEL III, LARGE 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
- 1,148
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 100 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.
See all 100 products in this recall →Related recalls
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