Customed Tummy Tuck Pack Recalled for Sterilization Validation Issues
Customed, Inc. is recalling Tummy Tuck 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 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 24 units of Tummy Tuck Pack-FJG (Code: 9003114, Lot: 141015595, Exp. 6/30/17). The product is 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 sterilization processes, as well as package integrity issues for products released for distribution as sterile. This means the products may not be sterile as intended.
The affected units were distributed only in Puerto Rico. Medical facilities and consumers should stop using the product and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- TUMMY TUCK PACK-FJG 6/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
- 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:9003114 Lot: 141015595 exp. 6/30/17
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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