Customed Cesarean Section Surgical Packs Recalled for Sterilization Defects
Customed, Inc. is recalling 32 units of Cesarean Section Surgical 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 is classified as FDA Class II. The hazard involves inadequate sterilization validation, which poses a risk of infection (risk-of-harm product), but no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Customed, Inc. is recalling 32 units of Cesarean Section Surgical Packs, Catalog Number 900998. 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 SL15208 (150719996) and SL15222 (150820360). The products were distributed only in Puerto Rico.
This is an FDA Class II recall. No specific instructions for consumers are provided in the source text, but the products should be returned to the supplier or disposed of according to local regulations.
The recalled product
- Product
- Catalog Number: 900998 CESAREAN SECTION 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
- 32
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: SL15208 (150719996) 31-JUL-16 SL15222 (150820360) 31-AUG-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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