Customed Face Lift Medical Kits Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 24 units of Face Lift medical kits 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 is classified as FDA Class II, which typically corresponds to a High severity score (3) when no hospitalizations or serious injuries are explicitly reported in the source text.
Plain-English summary
Customed, Inc. is recalling 24 units of Face Lift medical kits. These products 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 sterilization processes, as well as package integrity issues for products released for distribution as sterile.
The affected products are identified by code 9003083. The specific lots involved are 141015594 (expiration date 2/28/18) and 140714521 (expiration date 1/31/18). These products were distributed only in Puerto Rico.
The U.S. Food and Drug Administration has classified this recall as Class II. This classification indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The recalled product
- Product
- FACE LIFT 4/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 Kits
- Affected units
- 24
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:9003083 Lots: 141015594 exp. 2/28/18 140714521 exp. 1/31/18
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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