Customed Minor Laceration Tray Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 3,700 Minor Laceration Trays 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 medical device with a potential sterility failure (inadequate validation), which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Customed, Inc. is recalling 3,700 units of the Minor Laceration Tray (Catalog Number 9001765). 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 sterilization processes, as well as package integrity issues for products released for distribution as sterile. The affected lots are SL15199, SL15203, SL15232, SL15268, and SL15243.
The products were distributed only in Puerto Rico. Medical facilities that have received these trays should stop using them and contact the manufacturer for further instructions.
The recalled product
- Product
- Catalog Number: 9001765 MINOR LACERATION TRAY 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
- 3,700
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 100 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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