Customed Fanfold Drapes Recalled for Sterilization Process Validation Issues
Customed, Inc. is recalling Fanfold Drapes due to inadequate validation of sterilization processes and package integrity, posing a potential risk of infection.
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 (potential infection from non-sterile medical device) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria.
Plain-English summary
Customed, Inc. is recalling 3,180 units of Fanfold Drapes (44"x58, 60/CS) under FDA recall number Z-2695-2015. These medical drapes are used by medical staff for surgical procedures and patient care tasks such as wound healing, suture removals, and wound irrigation.
The recall was initiated because of inadequate validation and qualification of the sterilization processes and package integrity for products that were released for distribution as sterile. This defect means the products may not be sterile as intended, which could lead to patient infection if used.
The affected products were distributed only in Puerto Rico. Specific lot numbers and expiration dates are listed in the structured product information. Consumers and medical facilities should stop using these products and contact the manufacturer or their supplier for instructions on return or replacement.
The recalled product
- Product
- FANFOLD DRAPE 44"X58 60/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 Drapes
- Affected units
- 3,180
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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