Customed Wound Closure Tray Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 8,050 Wound Closure Tray I units 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 inadequate sterilization validation, and no injuries or illnesses have been reported.
Plain-English summary
Customed, Inc. is recalling 8,050 units of the Wound Closure Tray I (Catalog number 900063). These trays are used by medical staff to perform surgical procedures and patient care procedures 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 released for distribution as sterile. The affected lots include 141015607, 150116692, 150217226, 150317576, 150418229, 150518600, and 150619102, with expiration dates ranging from September 30, 2015, to May 31, 2016.
The affected products were distributed only in Puerto Rico. The source text does not specify the actions consumers or medical facilities should take, nor does it report any illnesses or injuries associated with the use of these products.
The recalled product
- Product
- WOUND CLOSURE TRAY I CUSTOMED 50/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 Trays
- Affected units
- 8,050
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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