Customed Utility Drapes Recalled for Sterilization Validation Issues
Customed, Inc. is recalling Utility Drapes due to inadequate validation of sterilization processes and package integrity.
What this means for you
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 (inadequate sterilization validation) and no injuries or illnesses have been reported in the source text.
Plain-English summary
Customed, Inc. is recalling 1,200 units of Utility Drapes (Lot 140915162, Code 900582, expiration 2/28/16). These products are used by medical staff for surgical procedures and patient care, including wound healing and suture removals.
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 affected units were distributed only in Puerto Rico.
The source text does not specify instructions for consumers or healthcare providers regarding the disposal or return of these products.
The recalled product
- Product
- UTILITY DRAPE END PRODUCT 50PK/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
- 1,200
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:900582 Lot: 140915162 exp. 2/28/16
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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