Customed Labor and Delivery Surgical Packs Recalled for Sterilization Issues
Customed, Inc. is recalling 44 Labor and Delivery Surgical Packs 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 risk-of-harm product (sterile surgical packs) where the hazard is theoretical (inadequate sterilization validation) and no injuries or illnesses have been reported in the source text.
Plain-English summary
Customed, Inc. is recalling 44 units of the Labor and Delivery Surgical Pack (Catalog Number 900419). 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 lots are SL15180 (150619283), SL15194 (150719803), and SL15243 (150820325 and 150820324).
The products were distributed only in Puerto Rico. No specific instructions for consumers or medical staff are provided in the source text regarding immediate actions to take.
The recalled product
- Product
- Catalog Number: 900419 LABOR & DELIVERY SURGICAL PACK 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 Packs
- Affected units
- 44
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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