Customed Surgical Gowns Recalled for Sterilization Process Validation Issues
Customed, Inc. is recalling 96 surgical gowns distributed in Puerto Rico 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 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 medical device) where the hazard is theoretical due to process validation issues, and no injuries or illnesses have been reported in the source text.
Plain-English summary
Customed, Inc. is recalling 96 units of Catalog Number 9003190 SURG GOWN SMS AMMI IV FULL. These surgical 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 because of inadequate validation and qualification of the sterilization processes and package integrity for products released for distribution as sterile. The specific lots involved are SL15195-02 (150619269) with a date of 31-JUL-16 and SL15251 (150820570) with a date of 31-AUG-16.
Medical facilities and consumers in Puerto Rico who possess these specific lots should stop using the products and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Catalog Number: 9003190 SURG GOWN SMS AMMI IV FULL 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
- 96
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)
- LOTS: SL15195-02 (150619269) 31-JUL-16 SL15251 (150820570) 31-AUG-16
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.
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