Customed Recalls Pery Gyn Packs Due to Sterility Compromise
Customed, Inc. is recalling 475 Pery Gyn Packs because significant sterility compromises and manufacturing deficiencies may result in patient infection.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source explicitly states that the sterility compromise 'may result in patient infection,' which constitutes a significant injury risk. This aligns with the rubric criterion for 'significant injury/property-damage reports' or high-risk products where injury is a direct consequence of the defect.
Plain-English summary
Customed, Inc. is recalling 475 units of the Pery Gyn Pack, catalog number 900-635. These medical supplies are used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation. The affected lots are 140513250, 140613842, 140714397, and 140814960.
The recall was initiated due to significant compromised sterility, which is not limited to potentially damaged packaging. Serious deficiencies in manufacturing processes and uncontrolled, inadequate storage conditions increase the risk of contamination. These conditions may result in patient infection.
The affected products were distributed in the United States to Florida, New York, and Puerto Rico. Medical facilities that have received these products should stop using them and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Pery Gyn Pack, Catalog number 900-635. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Manufacturer
- Customed, Inc
- Affected units
- 475
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 140513250 140613842 140714397 140814960
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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