Customed Peri Gyn Pack Recalled for Compromised Sterility
Customed, Inc. is recalling 180 units of Peri Gyn Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a medical device with compromised sterility that may result in patient infection, which aligns with the rubric criterion for 'significant injury/property-damage reports' or high-risk contamination in a medical context, warranting a Severe rating.
Plain-English summary
Customed, Inc. is recalling 180 units of Peri Gyn Packs, Catalog number 900-1716. These medical supplies are used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation.
The recall is being conducted because of compromised sterility, which is not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
The affected products were distributed in the United States to Florida, New York, and Puerto Rico. The specific lot numbers involved are 140513108, 140613625, 140714199, 140814673, and 140915236. Healthcare facilities should stop using these products and contact the manufacturer for instructions on return or disposal.
The recalled product
- Product
- Peri Gyn Pack, Catalog number 900-1716. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Manufacturer
- Customed, Inc
- Hazard
- Affected units
- 180
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)
- Lot numbers 140513108 140613625 140714199 140814673 140915236
Distribution
Part of a larger recall action
This product is one of 179 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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