Customed Face Packs Recalled Due to Sterilization Validation Issues
Customed, Inc. is recalling 16 units of Face Packs in Puerto Rico because the sterilization process and package integrity were not adequately validated.
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 (potential lack of sterility) and no injuries or illnesses have been reported, fitting the 'High' severity criteria.
Plain-English summary
Customed, Inc. is recalling 16 units of Face Packs (Code 9003116, Lot 141015597, expiration 10/31/15). These medical devices 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 the sterilization processes and package integrity for these products were not adequately validated or qualified before they were released for distribution as sterile. This means there is a risk that the products may not be sterile as intended.
The affected units were distributed only in Puerto Rico. Consumers and medical facilities should stop using these specific units and contact the manufacturer or their supplier for instructions on how to return or dispose of the product.
The recalled product
- Product
- FACE PACK FJG 8/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
- Affected units
- 16
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:9003116 Lot: 141015597 exp. 10/31/15
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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