Customed Premium Cesarean Pack Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 45 Premium Cesarean 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 surgical pack) 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 45 units of the Premium Cesarean Pack (Catalog Number 9001294). These sterile medical packs 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 the sterilization processes, as well as package integrity issues for products released for distribution as sterile. The affected lots are SL15202 and SL15203, both with a use-by date of July 31, 2016.
The products were distributed only in Puerto Rico. Consumers and healthcare facilities should stop using the recalled products and contact the manufacturer for further instructions.
The recalled product
- Product
- Catalog Number: 9001294 PREMIUM CESAREAN 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
- 45
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)
- LOTS: SL15202 (150719828) 31-JUL-16 SL15203 (150719828) 31-JUL-16
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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