Customed Hair Restoration Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 18 units of Hair Restoration Packs 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 medical device with a risk of harm (inadequate sterilization) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Customed, Inc. is recalling 18 units of Hair Restoration Packs (Code 9002966) because of inadequate validation and qualification of sterilization processes, as well as package integrity issues for products released as sterile. The affected lots are 150116592, 150116593, and 150116594, all with an expiration date of 1/31/16.
These products are used by medical staff to perform surgical procedures and patient care procedures, such as wound healing and suture removals. The recall is limited to products distributed only in Puerto Rico.
No specific instructions for consumers or medical providers are provided in the source text regarding how to handle the recalled items.
The recalled product
- Product
- HAIR RESTORATION PACK-THR 12/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
- 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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